AccessGUDID - DEVICE: Shockwave S4 (M732S4IVL40400)

GUDID

Device Identifier (DI) Information

Brand Name: Shockwave S4
Version or Model: 4.0mm x 40mm
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: S4IVL4040
Company Name: Shockwave Medical, Inc.

Primary DI Number: M732S4IVL40400
Issuing Agency: HIBCC
Commercial Distribution End Date: December 16, 2020
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:	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?
59026	Ultrasound thrombolysis system catheter, peripheral	A flexible tube designed for the percutaneous intravascular administration of high-frequency, low-energy ultrasound and drugs [e.g., tissue plasminogen activator (tPA)] for the disruption of clotted blood (i.e., a thrombus or thromboembolus) in a peripheral artery. It typically consists of a side-hole drug infusion catheter with a multi-element ultrasound core wire. The ultrasound is intended to prepare the clot by unwinding the fibrin strands, therefore enabling increased drug permeation through the clot to the vessel wall. It is a component of a system that includes a control unit to deliver the ultrasound. 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 [?]
Premarket Submission Number Not Available/Not Released

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): 0.054 Inch
Balloon Diameter: 4.0 Millimeter
Balloon Length: 40 Millimeter
Introducer Sheath Compatibility: 5 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: 06ddcd50-9859-44f4-9718-4eb9770c4344
Public Version Date: April 21, 2021
Public Version Number: 4
DI Record Publish Date: December 14, 2018