Product Code: MSB FDA class 2 21 CFR 876.5880

System And Accessories, Isolated Heart, Transport And Preservation

Gastroenterology, Urology

The Isolated Heart Transport and Preservation System and Accessories is a specialized device used to maintain a donor heart in a viable, isolated state during transport from the procurement site to the transplant center. It is classified as FDA Class 2, requiring a 510(k) premarket notification to demonstrate substantial equivalence prior to marketing. The product code is MSB, regulated under 21 CFR 876.5880, and falls under the Gastroenterology and Urology specialty panel. This device is not an implant and is not classified as life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MSB
Device Class: FDA class 2
Regulation Number: 876.5880
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K222535	OCS Lung Donor Flush Set	Nov 18, 2022	Substantially Equivalent	TransMedics, Inc.
K211314	OCS Lung Solution	Jul 29, 2021	Substantially Equivalent	TransMedics, Inc.
K190063	Servator C SALF Solution	Aug 14, 2019	Substantially Equivalent	S.A.L.F. Spa
K182735	Paragonix SherpaPak Cardiac Transport System	Oct 19, 2018	Substantially Equivalent	Paragonix Technologies
K180194	SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System	Mar 30, 2018	Substantially Equivalent	Paragonix Technologies, Inc.
K143074	Sherpa Pak Cardiac Transport System	Nov 25, 2014	Unknown	Paragonix Technologies, Inc.
K133432	SHERPA PAK CARDIAC TRANSPORT SYSTEM	Feb 21, 2014	Substantially Equivalent	Paragonix Technologies, Inc.
K123326	SHERPA PAK CARDIAC TRANSPORT SYSTEM	Feb 06, 2013	Substantially Equivalent	Paragonix Technologies, Inc.
K081997	PERFADEX WITH THAM	Oct 09, 2008	Substantially Equivalent	Vitrolife Sweden AB
K032794	CUSTODIOL	Apr 05, 2004	Substantially Equivalent	Dr. Franz Kohler Chemie GmbH
K022730	PERFADEX SOLUTION FOR LUNG PRESERVATION	Oct 27, 2003	Substantially Equivalent	Vitrolife AB
K000881	PERFADEX SOLUTION FOR ORGAN PRESERVATION	Mar 08, 2001	Substantially Equivalent	Vitrolife Sweden AB
K991594	CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS	Aug 05, 1999	Substantially Equivalent	Sangstat Medical Corp.