Duns Number:055514478
Device Description: The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate lithotripsy energy within the IVL balloon catheter.
Catalog Number
IVLCC
Brand Name
Shockwave Intravascular Lithotripsy (IVL) Connector Cable
Version/Model Number
825DP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K191840,P200039
Product Code
PPN
Product Code Name
Percutaneous Catheter, Ultrasound
Public Device Record Key
421d8bdf-9e78-47c3-b2b9-fb74f6e34e50
Public Version Date
April 21, 2021
Public Version Number
3
DI Record Publish Date
February 11, 2021
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 |