Home GUDID 00195451001093 Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter
Primary DI 00195451001093
Brand Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter
Company Shockwave Medical, Inc.
Model E8IVL080080
Catalog number E8IVL080080
Device 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 ultrasonic 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. The IVL Catheter comprises an array of integrated lithotripsy emitters for the localized delivery of ultrasonic acoustic pressure waves and an integrated balloon. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in eight (8) sizes: 2.5 x 80mm, 3.0 x 80mm, 3.5 x 80mm, 4.0 x 80mm, 5.0 x 80mm, 6.0 x 80mm, 7.0 x 80mm, and 8.0 x 80mm. The E8 Peripheral IVL Catheter sizes 2.5x80mm to 6.0x80mm are compatible with a 5-6 F sheath. The E8 Peripheral IVL Catheter sizes 7.0x80mm and 8.0x80mm are compatible with a 7 F sheath.
Published 2026-09-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name PPN Percutaneous Catheter, Ultrasound
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PPN Percutaneous Catheter, Ultrasound Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00195451001093 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00195451001093 00195451001093 195451001093 0195451001093
GMDN Terms# Term, Definition table Term Definition Intravascular lithotripsy system catheter, balloon, peripheral An electrically-powered, flexible tube, with an inflatable balloon at its distal end, intended to be introduced into a peripheral artery (excludes coronary and cerebral arteries) to transmit ultrasonic acoustic pressure waves circumferentially for the modification and fragmentation of calcified plaque, to improve vessel compliance. It includes transducers intended to convert electrical to ultrasonic energy, and a balloon to facilitate energy transmission and vessel dilation. It is used in conjunction with a dedicated control unit/generator (not included). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Balloon Diameter 0 Balloon Length 0 Catheter Length 0 Guidewire Diameter 0 Introducer Sheath Compatibilit 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from sunlight Special Storage Condition, Specify 0 0 Keep dry Special Storage Condition, Specify 0 0 Store the IVL Catheter in a cool, dark, dry place. Storage of the device in extreme conditions may damage the device and/or affect device performance that could lead to patient injury.
Regulatory Flags# DUNS number 055514478 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00195451001086 Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL070080 E8IVL070080 2026-09-29 00195451000836 Shockwave CS Guide Catheter Shockwave CS Guide Catheter SWCSGC01 2025-06-02 00195451000003 Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter C2PIVL2512 C2PIVL2512 2023-08-16 00195451000010 Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter C2PIVL3012 C2PIVL3012 2023-08-16 00195451000027 Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter C2PIVL3512 C2PIVL3512 2023-08-16 00195451000034 Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter C2PIVL4012 C2PIVL4012 2023-08-16 00195451001123 Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter C2AFIVL2512 C2AFIVL2512 2026-05-14 00195451001130 Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter C2AFIVL3012 C2AFIVL3012 2026-05-14 00195451001147 Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter C2AFIVL3512 C2AFIVL3512 2026-05-14 00195451001154 Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter C2AFIVL4012 C2AFIVL4012 2026-05-14 00195451000799 Shockwave IVL System with the Shockwave Javelin Peripheral IVL Catheter JVNPIVLF JVNPIVLF 2024-10-09 00195451000591 Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter C2AIVL2512 C2AIVL2512 2025-07-10 00195451000607 Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter C2AIVL3012 C2AIVL3012 2025-07-10 00195451000614 Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter C2AIVL3512 C2AIVL3512 2025-07-10 00195451000621 Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter C2AIVL4012 C2AIVL4012 2025-07-10 00195451000539 Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL025080 E8IVL025080 2024-04-17 00195451000546 Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL030080 E8IVL030080 2024-04-17 00195451000553 Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL035080 E8IVL035080 2024-04-17 00195451000560 Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL040080 E8IVL040080 2024-04-17 00195451000577 Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL050080 E8IVL050080 2024-04-17
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