Shockwave S4 S4IVL3040
GUDID 00195451000058
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
Ultrasound thrombolysis system catheter, peripheral| Primary Device ID | 00195451000058 |
| NIH Device Record Key | 9167aaf4-6d06-4008-a552-0b9de5368bb4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shockwave S4 |
| Version Model Number | 3.0 x 40mm |
| Catalog Number | S4IVL3040 |
| Company DUNS | 055514478 |
| Company Name | Shockwave Medical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com |
Device Dimensions
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Catheter Working Length | 135 Centimeter |
| Balloon Proximal Outer Diamete | 0.052 Inch |
| Balloon Diameter | 3 Millimeter |
| Balloon Length | 40 Millimeter |
| Introducer Sheath Compatibilit | 5 French |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195451000058 [Primary] |
| HIBCC | M732S4IVL30400 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191840
FDA Product Code
| PPN | Percutaneous Catheter, Ultrasound |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-12 |
| Device Publish Date | 2021-02-04 |
On-Brand Devices [Shockwave S4]
| M732S4IVL40400 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| M732S4IVL35400 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| M732S4IVL30400 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| M732S4IVL25400 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000072 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000065 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000058 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000041 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000348 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000331 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000324 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000317 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
Trademark Results [Shockwave S4]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SHOCKWAVE S4 87787693 5814411 Live/Registered |
Shockwave Medical, Inc. 2018-02-07 |
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