Shockwave S4 S4IVL4040

GUDID M732S4IVL40400

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.

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Primary Device IDM732S4IVL40400
NIH Device Record Key06ddcd50-9859-44f4-9718-4eb9770c4344
Commercial Distribution StatusIn Commercial Distribution
Brand NameShockwave S4
Version Model Number4.0mm x 40mm
Catalog NumberS4IVL4040
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 Kitfalse
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
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

Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Proximal Outer Diamete0.054 Inch
Balloon Diameter4 Millimeter
Balloon Length40 Millimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM732S4IVL40400 [Primary]

FDA Product Code

PPNPercutaneous Catheter, Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-01-14
Device Publish Date2018-12-14

On-Brand Devices [Shockwave S4]

M732S4IVL40400The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
M732S4IVL35400The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
M732S4IVL30400The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
M732S4IVL25400The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000072The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000065The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000058The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000041The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000348The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000331The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000324The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000317The 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
SHOCKWAVE S4
87787693 5814411 Live/Registered
Shockwave Medical, Inc.
2018-02-07

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