Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter L6IVL120030

GUDID 00195451000416

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm. The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable.

Shockwave Medical, Inc.

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Primary Device ID00195451000416
NIH Device Record Keyfb136168-c6bc-42e5-a84c-39f493143b5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameShockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter
Version Model Number12.0x30mm
Catalog NumberL6IVL120030
Company DUNS055514478
Company NameShockwave Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com

Device Dimensions

Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere
Catheter Working Length110 Centimeter
Balloon Proximal Outer Diamete0.104 Inch
Balloon Diameter12 Millimeter
Balloon Length30 Millimeter
Introducer Sheath Compatibilit8 French
Guidewire Diameter0.018 Inch
Balloon Nominal (Inflation) Pr2 Atmosphere
Balloon Nominal (Inflation) Pr3 Atmosphere
Balloon Nominal (Inflation) Pr4 Atmosphere
Balloon Rated Burst Pressure6 Atmosphere

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from heat

Device Identifiers

Device Issuing AgencyDevice ID
GS100195451000416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PPNPercutaneous Catheter, Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-01
Device Publish Date2022-10-24

On-Brand Devices [Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter]

00195451000416The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
00195451000409The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
00195451000393The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
00195451000386The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
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