Product code MSB— Gastroenterology, Urology
SHERPA PAK CARDIAC TRANSPORT SYSTEM
- Classification name
- System And Accessories, Isolated Heart, Transport And Preservation
- Device class
- Class 2
- Regulation
- 21 CFR 876.5880
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code MSB
FDA has cleared devices under product code MSB between 1999 and 2022, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2022
- 2021
- 2019
- 2018
- 2014
- 2013
- 2008
- 2004
- 2003
- 2001
- 1999
Top applicants under product code MSB
Recent clearances under product code MSB
- K222535 — OCS Lung Donor Flush Set
- K211314 — OCS Lung Solution
- K190063 — Servator C SALF Solution
- K182735 — Paragonix SherpaPak Cardiac Transport System
- K180194 — SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
- K143074 — Sherpa Pak Cardiac Transport System
- K133432 — SHERPA PAK CARDIAC TRANSPORT SYSTEM
- K123326 — SHERPA PAK CARDIAC TRANSPORT SYSTEM
- K081997 — PERFADEX WITH THAM
- K032794 — CUSTODIOL
- K022730 — PERFADEX SOLUTION FOR LUNG PRESERVATION
- K000881 — PERFADEX SOLUTION FOR ORGAN PRESERVATION
- K991594 — CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.