Javelin Peripheral IVL Catheter JVNPIVLF

GUDID 00195451000799

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.

Shockwave Medical, Inc.

Intravascular lithotripsy system balloon catheter, peripheral
Primary Device ID00195451000799
NIH Device Record Key8d886d72-7a6d-491e-926a-95c4cd4a8b93
Commercial Distribution StatusIn Commercial Distribution
Brand NameJavelin Peripheral IVL Catheter
Version Model NumberJavelin Peripheral IVL Catheter
Catalog NumberJVNPIVLF
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 Datetrue
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

Device Dimensions

Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Catheter Working Length150 Centimeter
Introducer Sheath Compatibilit5 French
Guidewire Diameter0.014 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100195451000799 [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 Date2024-10-17
Device Publish Date2024-10-09

Devices Manufactured by Shockwave Medical, Inc.

00195451000799 - Javelin Peripheral IVL Catheter2024-10-17The 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.
00195451000799 - Javelin Peripheral IVL Catheter2024-10-17 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
00195451000539 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
00195451000546 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
00195451000553 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
00195451000560 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
00195451000577 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
00195451000584 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripher2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
00195451000003 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary2023-08-24 The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of th
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