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CryoValve® SG Pulmonary Human Heart Valve

FDA UDI

Class U (US FDA UDI)

by Artivion, Inc.

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 SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue. FDA UDI
Model / Reference
SGPV10 FDA UDI
Description
Pulmonary Valve SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue. FDA UDI

Identifiers

Catalog Number
SGPV10 FDA UDI
Primary DI / UDI-DI
00877234000454 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

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Manufacturer

Manufacturer
Artivion, Inc.

Sources (1)

  • FDA UDI a8883b37-cc16-4a84-ada3-bf4b493723cc 38 fields · synced Jun 6, 2026