Duns Number:055514478
Device Description: The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.
Catalog Number
IVLGCCD
Brand Name
Intravascular Lithotripsy (IVL) Generator and Connector Cable
Version/Model Number
825D
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
-
Product Code
PPN
Product Code Name
Percutaneous Catheter, Ultrasound
Public Device Record Key
cf0ebcf0-76d9-40fd-bf16-8fbdfcf1d5c9
Public Version Date
April 21, 2021
Public Version Number
4
DI Record Publish Date
June 17, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |