Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter

Basic Information

Brand Name: Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter
Primary DI: 00195451000591
Version / Model: C2AIVL2512
Catalog Number: C2AIVL2512
Company Name: Shockwave Medical, Inc.
Labeler DUNS: 055514478
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-07-10
Public Version: 4
Public Version Date: 2025-12-25
Public Version Status: Update
Public Device Record Key: f2c2bafb-0209-4371-bb71-99872504b421

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.

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QMG	Shockwave Intravascular Lithotripsy System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
66728	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195451000591	GS1

Customer Contacts

Phone: 1-877-775-4846
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P200039	015

Device Sizes

Type	Value	Unit
Balloon Length	12	Millimeter
Balloon Diameter	2.5	Millimeter
Balloon Proximal Outer Diameter (OD)	0.044	Inch
Catheter Length	138	Centimeter
Guidewire Compatibility	6	French

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Keep away from sunlight Keep dry P401 - store at.. a cool, dark, and dry place