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Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter

FDA UDI

Class II (US FDA UDI)

by Shockwave Medical, Inc.

Identity

Trade Name
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter FDA UDI
Generic Name
Intravascular lithotripsy system balloon catheter, peripheral FDA UDI
Device Name
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). FDA UDI
Model / Reference
S4IVL4040 FDA UDI
Description
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). FDA UDI

Identifiers

Catalog Number
S4IVL4040 FDA UDI
Primary DI / UDI-DI
00195451000072 FDA UDI
510(k) Number
K191840 FDA UDI
FDA Product Code
PPN FDA UDI
GMDN Term
Intravascular lithotripsy system balloon catheter, peripheral FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Working Length — 135 Centimeter FDA UDI
Balloon Proximal Outer Diameter (OD) — 0.054 Inch FDA UDI
Balloon Diameter — 4.0 Millimeter FDA UDI
Balloon Length — 40 Millimeter FDA UDI
Introducer Sheath Compatibility — 5 French FDA UDI
Guidewire Diameter — 0.014 Inch FDA UDI
Balloon Nominal (Inflation) Pressure — 6 Atmosphere FDA UDI
Balloon Rated Burst Pressure — 10 Atmosphere FDA UDI

Category: Intravascular lithotripsy system balloon catheter, peripheral

Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter by Shockwave Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Intravascular lithotripsy system balloon catheter, peripheral.

Cleared under the same submission

K191840 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shockwave Medical, Inc.

Sources (1)

  • FDA UDI c0af6d05-01b9-4d14-af37-39569875fa4d 38 fields · synced Jun 8, 2026