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Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter

FDA UDI

Class II (US FDA UDI)

by Shockwave Medical, Inc.

Identity

Trade Name
Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter FDA UDI
Generic Name
Intravascular lithotripsy system balloon catheter, peripheral FDA UDI
Device Name
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 acoustic pressure pulses 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 integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The Shockwave E8 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. 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 IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment. FDA UDI
Model / Reference
E8IVL035080 FDA UDI
Description
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 acoustic pressure pulses 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 integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The Shockwave E8 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. 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 IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment. FDA UDI

Identifiers

Catalog Number
E8IVL035080 FDA UDI
Primary DI / UDI-DI
00195451000553 FDA UDI
510(k) Number
K240225 FDA UDI
FDA Product Code
PPN FDA UDI
OEZ FDA UDI
JAA 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
870.1200 FDA UDI
892.1650 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Balloon Length — 80 Millimeter FDA UDI
Balloon Diameter — 3.5 Millimeter FDA UDI
Balloon Proximal Outer Diameter (OD) — 0.056 Inch FDA UDI
Introducer Sheath Compatibility — 5 French FDA UDI
Length — 150 Centimeter FDA UDI

Category: Medical equipment/instrument drape, single-useIntravascular lithotripsy system balloon catheter, peripheral

Shockwave IVL System with the Shockwave E8 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

K240225 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 bba26826-422b-4f81-9548-9b528b7ee9ff 38 fields · synced May 30, 2026