Home GUDID 00195451001130 Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter
Primary DI 00195451001130
Brand Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter
Company Shockwave Medical, Inc.
Model C2AFIVL3012
Catalog number C2AFIVL3012
Device description The Shockwave C2 Aero Fly Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Aero Fly Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Fly is compatible with a 6F guiding catheter, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Published 2026-05-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name QMG Shockwave Intravascular Lithotripsy System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QMG Shockwave Intravascular Lithotripsy System Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00195451001130 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 00195451001130 00195451001130 195451001130 0195451001130
GMDN Terms# Term, Definition table Term Definition Intravascular lithotripsy system catheter, balloon, coronary An electrically-powered, flexible tube, with an inflatable balloon at its distal end, intended to be introduced into a coronary artery 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 3 Millimeter Balloon Length 12 Millimeter Balloon Proximal Outer Diamete 0.045 Millimeter Catheter Length 138 Centimeter Guidewire Compatibility 6 French
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from sunlight. Keep dry. Store the IVL Catheter in a cool, dark, dry place. Special Storage Condition, Specify 0 0 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 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 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 00195451000584 Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL060080 E8IVL060080 2024-04-17 00195451000386 Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL080030 L6IVL080030 2022-10-24 00195451000393 Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL090030 L6IVL090030 2022-10-24
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00195451001123 Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter Shockwave Medical, Inc. QMG 2026-05-14 00195451001147 Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter Shockwave Medical, Inc. QMG 2026-05-14 00195451001154 Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter Shockwave Medical, Inc. QMG 2026-05-14 00195451000591 Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter Shockwave Medical, Inc. QMG 2025-07-10 00195451000607 Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter Shockwave Medical, Inc. QMG 2025-07-10 00195451000614 Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter Shockwave Medical, Inc. QMG 2025-07-10 00195451000621 Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter Shockwave Medical, Inc. QMG 2025-07-10 00195451000003 Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter Shockwave Medical, Inc. QMG 2023-08-16 00195451000010 Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter Shockwave Medical, Inc. QMG 2023-08-16 00195451000027 Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter Shockwave Medical, Inc. QMG 2023-08-16 00195451000034 Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter Shockwave Medical, Inc. QMG 2023-08-16 00195451000355 Shockwave Medical IVL Generator and Connector Cable Shockwave Medical, Inc. QMG 2022-12-22 00195451000089 Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter Shockwave Medical, Inc. QMG 2021-02-17 00195451000096 Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter Shockwave Medical, Inc. QMG 2021-02-17 00195451000102 Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter Shockwave Medical, Inc. QMG 2021-02-17 00195451000119 Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter Shockwave Medical, Inc. QMG 2021-02-17 00195451000294 Shockwave Medical IVL Generator and Connector Cable Shockwave Medical, Inc. QMG 2021-02-11 00195451000300 Shockwave Medical IVL Generator and Connector Cable Shockwave Medical, Inc. QMG 2021-02-11 M732IVLGCCD0 Shockwave Medical IVL Generator and Connector Cable Shockwave Medical, Inc. QMG 2019-06-17 M732IVLCC0 Shockwave Medical IVL Generator and Connector Cable Shockwave Medical, Inc. QMG 2018-12-14 M732IVLGCC0 Shockwave Medical IVL Generator and Connector Cable Shockwave Medical, Inc. QMG 2018-12-14 M732LCC825D1 Lithoplasty® Shockwave Medical, Inc. QMG 2017-03-09
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