Duns Number:080251450
Device Description: ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledge ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
Catalog Number
-
Brand Name
ProxiCor for Cardiac Tissue Repair
Version/Model Number
CMCV-067-404
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
K063349,K063349
Product Code
DXZ
Product Code Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Public Device Record Key
95e52f4c-7ea0-49cf-997f-b94271e5ff79
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
July 01, 2015
Package DI Number
10859389005055
Quantity per Package
5
Contains DI Package
00859389005058
Package Discontinue Date
December 31, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |