CryoPatch® SG Pulmonary Human Cardiac Trunk Patch

FDA UDI

Class II (US FDA UDI)

by Artivion, Inc.

Identity

Trade Name: CryoPatch® SG Pulmonary Human Cardiac Trunk Patch FDA UDI
Generic Name: Cadaveric pulmonary artery bioprosthesis FDA UDI
Device Name: CryoPatch SG Pulmonary Trunk The CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue. FDA UDI
Model / Reference: SGP010 FDA UDI
Description: CryoPatch SG Pulmonary Trunk The CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue. FDA UDI

Identifiers

Catalog Number: SGP010 FDA UDI
Primary DI / UDI-DI: 00877234000478 FDA UDI
510(k) Number: K101866 FDA UDI
FDA Product Code: DXZ FDA UDI
GMDN Term: Cadaveric pulmonary artery bioprosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

Yes

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cadaveric pulmonary artery bioprosthesis

CryoPatch® SG Pulmonary Human Cardiac Trunk Patch by Artivion, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cadaveric pulmonary artery bioprosthesis.

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CardioGRAFT-MC™ — LIFENET HEALTH · Class II
CardioGRAFT-MC™ — LIFENET HEALTH · Class II
CardioGRAFT-MC™ — LIFENET HEALTH · Class II
CardioGRAFT-MC™ — LIFENET HEALTH · Class II
CardioGRAFT-MC™ — LIFENET HEALTH · Class II

Cleared under the same submission

K101866 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 II	Pending data

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Manufacturer

Manufacturer: Artivion, Inc.

Sources (1)

FDA UDI 8b36a2c4-0ae9-4ef5-b2e7-7d57c34d9609 38 fields · synced Jun 8, 2026