Duns Number:119253177
Device Description: Pulmonary Valve and Conduit SGThe CryoValve SG Pulmonary Human Heart Valve is a human hear Pulmonary Valve and Conduit SGThe CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.
Catalog Number
SGPV00
Brand Name
CryoValve® SG Pulmonary Human Heart Valve
Version/Model Number
SGPV00
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
K092021
Product Code
OHA
Product Code Name
Heart Valve, More Than Minimally Manipulated Allograft
Public Device Record Key
4c4920bc-1260-4e9e-905c-831bbbf0e84a
Public Version Date
July 24, 2018
Public Version Number
4
DI Record Publish Date
September 11, 2015
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. | 16 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 2 |