FDA.reportPublic FDA data

Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter

Primary DI
00195451000607
Brand
Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter
Company
Shockwave Medical, Inc.
Model
C2AIVL3012
Catalog number
C2AIVL3012
Device description
The Shockwave C2 Aero 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. 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 coronary arteries. 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 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 Coronary IVL Catheter 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
2025-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QMGShockwave Intravascular Lithotripsy System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMGShockwave Intravascular Lithotripsy SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200039015

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200039015Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.2021-02-12QMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195451000607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195451000607001954510006071954510006070195451000607

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular lithotripsy system balloon catheter, coronaryAn electrically-powered, flexible tube intended to be introduced into a coronary artery stiffened by a highly calcified atheromatous plaque, to transmit ultrasound (US) waves [e.g., acoustic pressure pulses] for the disruption of the plaque to improve vessel compliance. It is used in conjunction with a dedicated control unit/generator (not included) and includes transducers intended to convert electrical energy to ultrasound and an inflatable balloon at its distal end to facilitate energy transmission and dilation of the vessel. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter3Millimeter
Balloon Length12Millimeter
Balloon Proximal Outer Diamete0.045Inch
Catheter Length138Centimeter
Guidewire Compatibility6French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight Keep dry P401 - store at.. a cool, dark, and dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-775-4846cs@shockwavemedical.com

Regulatory Flags#

DUNS number
055514478
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195451000003Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL2512C2PIVL25122023-08-16
00195451000010Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL3012C2PIVL30122023-08-16
00195451000027Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL3512C2PIVL35122023-08-16
00195451000034Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL4012C2PIVL40122023-08-16
00195451001123Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL2512C2AFIVL25122026-05-14
00195451001130Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL3012C2AFIVL30122026-05-14
00195451001147Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL3512C2AFIVL35122026-05-14
00195451001154Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL4012C2AFIVL40122026-05-14
00195451000799Shockwave IVL System with the Shockwave Javelin Peripheral IVL CatheterJVNPIVLFJVNPIVLF2024-10-09
00195451000591Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterC2AIVL2512C2AIVL25122025-07-10
00195451000614Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterC2AIVL3512C2AIVL35122025-07-10
00195451000621Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterC2AIVL4012C2AIVL40122025-07-10
00195451000539Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL025080E8IVL0250802024-04-17
00195451000546Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL030080E8IVL0300802024-04-17
00195451000553Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL035080E8IVL0350802024-04-17
00195451000560Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL040080E8IVL0400802024-04-17
00195451000577Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL050080E8IVL0500802024-04-17
00195451000584Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL060080E8IVL0600802024-04-17
00195451000386Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterL6IVL080030L6IVL0800302022-10-24
00195451000393Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterL6IVL090030L6IVL0900302022-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195451001123Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterShockwave Medical, Inc.QMG2026-05-14
00195451001130Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterShockwave Medical, Inc.QMG2026-05-14
00195451001147Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterShockwave Medical, Inc.QMG2026-05-14
00195451001154Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterShockwave Medical, Inc.QMG2026-05-14
00195451000591Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterShockwave Medical, Inc.QMG2025-07-10
00195451000614Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterShockwave Medical, Inc.QMG2025-07-10
00195451000621Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterShockwave Medical, Inc.QMG2025-07-10
00195451000003Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterShockwave Medical, Inc.QMG2023-08-16
00195451000010Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterShockwave Medical, Inc.QMG2023-08-16
00195451000027Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterShockwave Medical, Inc.QMG2023-08-16
00195451000034Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterShockwave Medical, Inc.QMG2023-08-16
00195451000355Shockwave Medical IVL Generator and Connector CableShockwave Medical, Inc.QMG2022-12-22
00195451000089Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter Shockwave Medical, Inc.QMG2021-02-17
00195451000096Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter Shockwave Medical, Inc.QMG2021-02-17
00195451000102Shockwave IVL System with the Shockwave C2 Coronary IVL CatheterShockwave Medical, Inc.QMG2021-02-17
00195451000119Shockwave IVL System with the Shockwave C2 Coronary IVL CatheterShockwave Medical, Inc.QMG2021-02-17
00195451000294Shockwave Medical IVL Generator and Connector CableShockwave Medical, Inc.QMG2021-02-11
00195451000300Shockwave Medical IVL Generator and Connector CableShockwave Medical, Inc.QMG2021-02-11
M732IVLGCCD0Shockwave Medical IVL Generator and Connector CableShockwave Medical, Inc.QMG2019-06-17
M732IVLCC0Shockwave Medical IVL Generator and Connector CableShockwave Medical, Inc.QMG2018-12-14
M732IVLGCC0Shockwave Medical IVL Generator and Connector CableShockwave Medical, Inc.QMG2018-12-14
M732LCC825D1Lithoplasty®Shockwave Medical, Inc.QMG2017-03-09