AccessGUDID - DEVICE: Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter (00195451000102)

GUDID

Device Identifier (DI) Information

Brand Name: Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter
Version or Model: 3.5 x 12mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C2IVL3512
Company Name: Shockwave Medical, Inc.

Primary DI Number: 00195451000102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055514478 *Terms of Use

Device Description: The Shockwave C2 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 stenosis that are anticipated to exhibit resistance to full balloon dilation 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 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66728	Intravascular lithotripsy system balloon catheter, coronary	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QMG	Shockwave Intravascular Lithotripsy System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200039	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry and keep away from heat

Clinically Relevant Size

[?]

Size Type Text
Balloon Proximal Outer Diameter (OD): 0.045 Inch
Balloon Diameter: 3.5 Millimeter
Balloon Length: 12 Millimeter
Catheter Working Length: 138 Centimeter
Introducer Sheath Compatibility: 6 French
Guidewire Diameter: 0.014 Inch
Balloon Nominal (Inflation) Pressure: 6 Atmosphere
Balloon Rated Burst Pressure: 10 Atmosphere

Device Record Status

Public Device Record Key: c96c5812-11e3-4b31-bfba-dac07a214519
Public Version Date: April 05, 2023
Public Version Number: 2
DI Record Publish Date: February 17, 2021