Duns Number:080251450
Device Description: ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pe ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
Catalog Number
-
Brand Name
ProxiCor for Pericardial Closure
Version/Model Number
CMCV-060-402
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K051405,K051405
Product Code
DXZ
Product Code Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Public Device Record Key
abd70a9b-3877-4ffe-827b-81eba73791c6
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
June 30, 2015
Package DI Number
10859389005017
Quantity per Package
5
Contains DI Package
00859389005010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |