Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter

Basic Information

• Brand Name: Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter
• Primary DI: 00195451000331
• Version / Model: S4IVLK3540
• Catalog Number: S4IVLK3540
• Company Name: Shockwave Medical, Inc.
• Labeler DUNS: 055514478
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-08
• Public Version: 6
• Public Version Date: 2025-12-25
• Public Version Status: Update
• Public Device Record Key: e0f2e26f-7ee6-4473-beb9-4d7c842df552

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OEZ	Cardiovascular Procedure Kit	Cardiovascular	870.1200	2
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	870.1250	2
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	892.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
66729	Intravascular lithotripsy system catheter, balloon, peripheral	An electrically-powered, flexible tube, with an inflatable balloon at its distal end, intended to be introduced into a peripheral artery (excludes coronary and cerebral arteries) to transmit ultrasonic acoustic pressure waves circumferentially for the modification and fragmentation of calcified plaque, to improve vessel compliance. It includes transducers intended to convert electrical to ultrasonic energy, and a balloon to facilitate energy transmission and vessel dilation. It is used in conjunction with a dedicated control unit/generator (not included). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195451000331	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Catheter Working Length	135	Centimeter
Balloon Proximal Outer Diameter (OD)	0.054	Inch
Balloon Diameter	3.5	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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and away from heat