AccessGUDID - DEVICE: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary (00195451000027)

GUDID

Device Identifier (DI) Information

Brand Name: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary
Version or Model: 3.5x12mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C2PIVL3512
Company Name: Shockwave Medical, Inc.

Primary DI Number: 00195451000027
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+ 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+ 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+ is compatible with a 5F guiding catheter and extensions, 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

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	008

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 away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place

Clinically Relevant Size

[?]

Size Type Text
Balloon Length: 12 Millimeter
Balloon Diameter: 3.5 Millimeter
Balloon Proximal Outer Diameter (OD): 0.045 Inch
Length: 138 Centimeter
Guidewire Compatibility: 5 French

Device Record Status

Public Device Record Key: a2b23f06-9a27-4022-9e42-af89c2760f7c
Public Version Date: August 24, 2023
Public Version Number: 1
DI Record Publish Date: August 16, 2023