510(k) K222535
- Device
- OCS Lung Donor Flush Set
- Applicant
- TransMedics, Inc.
- 510(k) number
- K222535
- Product code
- MSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-18
- Date received
- 2022-08-22
- Regulation
- 876.5880
- Classification name
- System And Accessories, Isolated Heart, Transport And Preservation
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Miriam Provost
- Address
- 200 Minuteman Rd. Suite 302 Andover MA US 01810 01810
FDA Registration Numbers#
- 3007685782
- 3003708554
- 9615922
- 2123774
- 3011175555
- 1220477
- 3003152463
- 3031884833
- 3007583504
- 3024820181
- 3010034260
- 3010765841
- 1047843
- 3017223202
- 1420032
Source Documents#
Other 510(k) Records For Product Code MSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
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FDA Review#
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