Duns Number:128112195
Device Description: The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a sterile d The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst II is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths.
Catalog Number
-
Brand Name
Cardiva Catalyst II VCS
Version/Model Number
500-580C
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
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
-
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
b135dfbe-1045-42f5-be12-3a6cc28aa018
Public Version Date
August 23, 2019
Public Version Number
3
DI Record Publish Date
December 29, 2015
Package DI Number
M729500580C2
Quantity per Package
10
Contains DI Package
M729500580C0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10-pk carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |