AccessGUDID - DEVICE: Shockwave S4 (00195451000317)

GUDID

Device Identifier (DI) Information

Brand Name: Shockwave S4
Version or Model: 2.5x40mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S4IVLK2540
Company Name: Shockwave Medical, Inc.

Primary DI Number: 00195451000317
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055514478 *Terms of Use

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:	Yes
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
12535	Medical equipment/instrument drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEZ	Cardiovascular Procedure Kit
PPN	Percutaneous Catheter, Ultrasound
JAA	System, X-Ray, Fluoroscopic, Image-Intensified

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 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: a941277a-4c43-4edd-97b7-9682e0191dc1
Public Version Date: September 11, 2024
Public Version Number: 4
DI Record Publish Date: June 08, 2021