AccessGUDID - DEVICE: Shockwave S4 (00195451000041)

GUDID

Device Identifier (DI) Information

Brand Name: Shockwave S4
Version or Model: 2.5 x 40mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S4IVL2540
Company Name: Shockwave Medical, Inc.

Primary DI Number: 00195451000041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055514478 *Terms of Use
Previous DI: M732S4IVL25400

Device Description: The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).

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?
66729	Intravascular lithotripsy system balloon catheter, peripheral	An electrically-powered, flexible tube intended to be introduced into a peripheral 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
PPN	Percutaneous Catheter, Ultrasound

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191840	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 Rated Burst Pressure: 10 Atmosphere
Balloon Nominal (Inflation) Pressure: 6 Atmosphere
Guidewire Diameter: 0.014 Inch
Introducer Sheath Compatibility: 5 French
Balloon Length: 40 Millimeter
Balloon Diameter: 2.5 Millimeter
Balloon Proximal Outer Diameter (OD): 0.052 Inch
Catheter Working Length: 135 Centimeter

Device Record Status

Public Device Record Key: fe990cd1-0e99-4d45-8ea2-9d227260e564
Public Version Date: April 05, 2023
Public Version Number: 4
DI Record Publish Date: February 04, 2021