Identity
- Trade Name
- CryoValve® SG Pulmonary Human Heart Valve FDA UDI
- Generic Name
- Cadaveric heart valve prosthesis, decellularized, non-sterile FDA UDI
- Device Name
- Pulmonary Valve and Conduit SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue. FDA UDI
- Model / Reference
- SGPV00 FDA UDI
- Description
- Pulmonary Valve and Conduit SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue. FDA UDI
Identifiers
- Catalog Number
- SGPV00 FDA UDI
- Primary DI / UDI-DI
- 00877234000447 FDA UDI
- 510(k) Number
- K092021 FDA UDI
- FDA Product Code
- OHA FDA UDI
- GMDN Term
- Cadaveric heart valve prosthesis, decellularized, non-sterile FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cadaveric heart valve prosthesis, decellularized, non-sterile
CryoValve® SG Pulmonary Human Heart Valve by Artivion, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cadaveric heart valve prosthesis, decellularized, non-sterile.
Cleared under the same submission
K092021 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Artivion, Inc.
Sources (1)
- FDA UDI 4c4920bc-1260-4e9e-905c-831bbbf0e84a 38 fields · synced Jun 8, 2026