Shockwave S4 - The Shockwave S4 Intravascular Lithotripsy (IVL) - Shockwave Medical, Inc.

Duns Number:055514478

Device Description: The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniatur 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).

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More Product Details

Catalog Number

S4IVL4040

Brand Name

Shockwave S4

Version/Model Number

4.0 x 40mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191840

Product Code Details

Product Code

PPN

Product Code Name

Percutaneous Catheter, Ultrasound

Device Record Status

Public Device Record Key

c0af6d05-01b9-4d14-af37-39569875fa4d

Public Version Date

July 09, 2021

Public Version Number

3

DI Record Publish Date

February 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHOCKWAVE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 56
3 A medical device with high risk that requires premarket approval 4