Product code MSB
- Device name
- System And Accessories, Isolated Heart, Transport And Preservation
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5880
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222535 | OCS Lung Donor Flush Set | TransMedics, Inc. | 2022-11-18 |
| K211314 | OCS Lung Solution | TransMedics, Inc. | 2021-07-29 |
| K190063 | Servator C SALF Solution | S.A.L.F. Spa | 2019-08-14 |
| K182735 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies | 2018-10-19 |
| K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | 2018-03-30 |
| K143074 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2014-11-25 |
| K133432 | SHERPA PAK CARDIAC TRANSPORT SYSTEM | Paragonix Technologies, Inc. | 2014-02-21 |
| K123326 | SHERPA PAK CARDIAC TRANSPORT SYSTEM | Paragonix Technologies, Inc. | 2013-02-06 |
| K081997 | PERFADEX WITH THAM | Vitrolife Sweden AB | 2008-10-09 |
| K032794 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | 2004-04-05 |
| K022730 | PERFADEX SOLUTION FOR LUNG PRESERVATION | Vitrolife AB | 2003-10-27 |
| K000881 | PERFADEX SOLUTION FOR ORGAN PRESERVATION | Vitrolife Sweden AB | 2001-03-08 |
| K991594 | CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS | Sangstat Medical Corp. | 1999-08-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08052742104456 | Servator C SALF Solution | S.A.L.F. SPA LABORATORIO FARMACOLOGICO | 2026-05-26 |
| 08052742104425 | Servator H SALF Solution | S.A.L.F. SPA LABORATORIO FARMACOLOGICO | 2026-05-26 |
| 08052742104418 | Servator H SALF Solution | S.A.L.F. SPA LABORATORIO FARMACOLOGICO | 2026-05-26 |
| 08052742104401 | Servator H SALF Solution | S.A.L.F. SPA LABORATORIO FARMACOLOGICO | 2026-05-26 |
| 40331330005006 | Custodiol | Dr. Franz Köhler Chemie GmbH | 2025-09-19 |
| 40331330020009 | Custodiol | Dr. Franz Köhler Chemie GmbH | 2025-09-19 |
| 40331330010000 | Custodiol | Dr. Franz Köhler Chemie GmbH | 2025-09-19 |
| 00850005470649 | SherpaPak Cardiac Transport System (CTS) | Paragonix Technologies Inc | 2025-05-05 |
| 04033133420007 | Custodiol(R) | Dr. Franz Köhler Chemie GmbH | 2023-07-03 |
| B00958753 | OCS Lung Donor Flush Set | TRANSMEDICS, INC. | 2023-06-13 |
| B00958755 | OCS Lung Donor Flush Set | TRANSMEDICS, INC. | 2023-06-13 |
| 13700911900126 | CELSIOR Cold Storage Solution | INSTITUT GEORGES LOPEZ | 2022-02-07 |
| 00851983008060 | Servator H | GLOBAL TRANSPLANT SOLUTIONS, INC. | 2020-04-21 |
| 04033133611016 | Custodiol(R) | Dr. Franz Köhler Chemie GmbH | 2019-08-08 |
| 04033133610002 | Custodiol(R) | Dr. Franz Köhler Chemie GmbH | 2019-05-09 |
| 04033133250000 | Custodiol(R) | Dr. Franz Köhler Chemie GmbH | 2019-05-09 |
| 04033133105003 | Custodiol(R) | Dr. Franz Köhler Chemie GmbH | 2019-05-09 |
| 00869582000378 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies Inc | 2019-02-15 |
| 00869582000385 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies Inc | 2019-02-15 |
| 00869582000361 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies Inc | 2019-02-15 |
| 00869582000354 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies Inc | 2019-02-15 |
| 00869582000347 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies Inc | 2019-02-15 |
| 00869582000330 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies Inc | 2019-02-15 |
| 00869582000323 | Paragonix SherpaPak Cardiac Transport System | PARAGONIX TECHNOLOGIES INC | 2019-02-15 |
| 10869582000313 | Paragonix SherpaPak Cardiac Transport System | PARAGONIX TECHNOLOGIES INC | 2019-02-15 |
| 10850005470271 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies Inc | 2019-02-15 |
| 00869582000316 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies Inc | 2019-02-15 |
| B00944670 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| 40331330610002 | Custodiol | Dr. Franz Köhler Chemie GmbH | 2016-09-22 |