Device
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 difficul...
Manufacturer
Shockwave Medical, Inc.
Shockwave Medical, Inc.
Model: C2AFIVL4012
Catalog: C2AFIVL4012
DI: 00195451001154
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
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.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
60eb2aaa-5df6-41b3-8141-0eb110f9288e
Distribution Status:
In Commercial Distribution
DUNS Number:
055514478
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00195451001154
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66728
Name: Intravascular lithotripsy system catheter, balloon, coronary
Definition:
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.
FDA Product Codes
QMG
Shockwave Intravascular Lithotripsy System
Premarket Submissions
Submission Number:
P200039
Supplement Number:
019
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
0.047
Item #1 - Size Type:
Balloon Proximal Outer Diameter (OD)
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
4
Item #2 - Size Type:
Balloon Diameter
Item #3 - Size - @attributes - Unit:
Millimeter
Item #3 - Size - @attributes - Value:
12
Item #3 - Size Type:
Balloon Length
Item #4 - Size - @attributes - Unit:
Centimeter
Item #4 - Size - @attributes - Value:
138
Item #4 - Size Type:
Catheter Length
Item #5 - Size - @attributes - Unit:
French
Item #5 - Size - @attributes - Value:
6
Item #5 - Size Type:
Guidewire Compatibility
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Keep away from sunlight. Keep dry. Store the IVL Catheter in a cool, dark, dry place.
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Storage of the device in extreme conditions may damage the device and/or affect device performance that could lead to patient injury