MSB — System And Accessories, Isolated Heart, Transport And Preservation Class II
FDA product code MSB covers "System And Accessories, Isolated Heart, Transport And Preservation", a Class II medical device regulated under 21 CFR 876.5880. Submissions are reviewed by the Gastroenterology, Urology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MSB
- Device Class
- Class II
- Regulation Number
- 876.5880
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K222535 | transmedics | OCS Lung Donor Flush Set | November 18, 2022 |
| K211314 | transmedics | OCS Lung Solution | July 29, 2021 |
| K190063 | s.a.l.f | Servator C SALF Solution | August 14, 2019 |
| K182735 | paragonix technologies | Paragonix SherpaPak Cardiac Transport System | October 19, 2018 |
| K180194 | paragonix technologies | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | March 30, 2018 |
| K143074 | paragonix technologies | Sherpa Pak Cardiac Transport System | November 25, 2014 |
| K133432 | paragonix technologies | SHERPA PAK CARDIAC TRANSPORT SYSTEM | February 21, 2014 |
| K123326 | paragonix technologies | SHERPA PAK CARDIAC TRANSPORT SYSTEM | February 6, 2013 |
| K081997 | vitrolife sweden | PERFADEX WITH THAM | October 9, 2008 |
| K032794 | franz kohler chemie | CUSTODIOL | April 5, 2004 |
| K022730 | vitrolife | PERFADEX SOLUTION FOR LUNG PRESERVATION | October 27, 2003 |
| K000881 | vitrolife sweden | PERFADEX SOLUTION FOR ORGAN PRESERVATION | March 8, 2001 |
| K991594 | sangstat medical | CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS | August 5, 1999 |