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Shockwave IVL System with the Shockwave Javelin Peripheral IVL Catheter

FDA UDI

Class II (US FDA UDI)

by Shockwave Medical, Inc.

Identity

Trade Name
Shockwave IVL System with the Shockwave Javelin 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. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in peripheral arteries. Energizing the intravascular lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion. The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter consists of three main components: the IVL Catheter, the IVL Generator, and the IVL Connector Cable. The Shockwave Javelin IVL Catheter is comprised of a catheter with an integrated emitter located near the distal end to enable the localized delivery of acoustic pressure pulses in the peripheral vasculature. The emitter is radiopaque to facilitate catheter visibility under fluoroscopy and is surrounded by a fluid-filled space (IVL window) that allows for the transmission of acoustic pressure pulses. The Shockwave Javelin Peripheral IVL Catheter shaft contains a lumen to pressurize and a lumen to de-pressurize the catheter with saline (the medium to create IVL), a guidewire lumen, and a lithotripsy emitter. The emitter is enclosed within a non-expandable polymer fluid-filled space (i.e., IVL window) containing saline that is connected to the proximal shaft, inlet and outlet ports, and is tapered down to the distal tip of the catheter. The IVL window is located near the distal tip of the catheter. The emitter is radiopaque to facilitate catheter visibility under fluoroscopy and is surrounded by the IVL window that allows for the transmission of acoustic pressure pulses. The IVL window is designed to provide a static catheter profile. FDA UDI
Model / Reference
JVNPIVLF 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. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in peripheral arteries. Energizing the intravascular lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion. The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter consists of three main components: the IVL Catheter, the IVL Generator, and the IVL Connector Cable. The Shockwave Javelin IVL Catheter is comprised of a catheter with an integrated emitter located near the distal end to enable the localized delivery of acoustic pressure pulses in the peripheral vasculature. The emitter is radiopaque to facilitate catheter visibility under fluoroscopy and is surrounded by a fluid-filled space (IVL window) that allows for the transmission of acoustic pressure pulses. The Shockwave Javelin Peripheral IVL Catheter shaft contains a lumen to pressurize and a lumen to de-pressurize the catheter with saline (the medium to create IVL), a guidewire lumen, and a lithotripsy emitter. The emitter is enclosed within a non-expandable polymer fluid-filled space (i.e., IVL window) containing saline that is connected to the proximal shaft, inlet and outlet ports, and is tapered down to the distal tip of the catheter. The IVL window is located near the distal tip of the catheter. The emitter is radiopaque to facilitate catheter visibility under fluoroscopy and is surrounded by the IVL window that allows for the transmission of acoustic pressure pulses. The IVL window is designed to provide a static catheter profile. FDA UDI

Identifiers

Catalog Number
JVNPIVLF FDA UDI
Primary DI / UDI-DI
00195451000799 FDA UDI
510(k) Number
K242213 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 1.5 Millimeter FDA UDI
Catheter Working Length — 150 Centimeter FDA UDI
Introducer Sheath Compatibility — 5 French FDA UDI
Guidewire Diameter — 0.014 Inch FDA UDI

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

Shockwave IVL System with the Shockwave Javelin 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.

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 8d886d72-7a6d-491e-926a-95c4cd4a8b93 38 fields · synced Jun 1, 2026