FDA Product Code
FDA Product Code MSB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5880
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261913 | X°Port Heart Preservation System | Traferox Technologies, Inc. | 2026-09-16 | Traditional | PDF ↗ |
| K222535 | OCS Lung Donor Flush Set | TransMedics, Inc. | 2022-11-18 | Traditional | PDF ↗ |
| K211314 | OCS Lung Solution | TransMedics, Inc. | 2021-07-29 | Traditional | PDF ↗ |
| K190063 | Servator C SALF Solution | S.A.L.F. Spa | 2019-08-14 | Traditional | PDF ↗ |
| K182735 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies | 2018-10-19 | Special | PDF ↗ |
| K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | 2018-03-30 | Traditional | PDF ↗ |
| K143074 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2014-11-25 | Special | PDF ↗ |
| K133432 | SHERPA PAK CARDIAC TRANSPORT SYSTEM | Paragonix Technologies, Inc. | 2014-02-21 | Traditional | PDF ↗ |
| K123326 | SHERPA PAK CARDIAC TRANSPORT SYSTEM | Paragonix Technologies, Inc. | 2013-02-06 | Traditional | PDF ↗ |
| K081997 | PERFADEX WITH THAM | Vitrolife Sweden AB | 2008-10-09 | Special | PDF ↗ |
| K032794 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | 2004-04-05 | Traditional | PDF ↗ |
| K022730 | PERFADEX SOLUTION FOR LUNG PRESERVATION | Vitrolife AB | 2003-10-27 | Traditional | PDF ↗ |
| K000881 | PERFADEX SOLUTION FOR ORGAN PRESERVATION | Vitrolife Sweden AB | 2001-03-08 | Traditional | PDF ↗ |
| K991594 | CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS | Sangstat Medical Corp. | 1999-08-05 | Traditional | PDF ↗ |
Product code MSB · Class II · Gastroenterology, Urology. Data: openFDA.