PERFADEX SOLUTION FOR LUNG PRESERVATION
FDA 510(k) clearance K022730 · decided 2003-10-27
Clearance details
- K-number
- K022730
- Device name
- PERFADEX SOLUTION FOR LUNG PRESERVATION
- Applicant
- Vitrolife AB
- Decision
- Substantially Equivalent
- Date received
- 2002-08-16
- Decision date
- 2003-10-27
- Days to decision
- 437 days
- Clearance type
- Traditional
- Product code
- MSB
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ringoes, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Paragonix SherpaPak Cardiac Transport System (K182735) | Paragonix Technologies | 2018-10-19 |
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| Sherpa Pak Cardiac Transport System (K143074) | Paragonix Technologies, Inc. | 2014-11-25 |
| SHERPA PAK CARDIAC TRANSPORT SYSTEM (K133432) | Paragonix Technologies, Inc. | 2014-02-21 |
| SHERPA PAK CARDIAC TRANSPORT SYSTEM (K123326) | Paragonix Technologies, Inc. | 2013-02-06 |
| PERFADEX WITH THAM (K081997) | Vitrolife Sweden AB | 2008-10-09 |
| CUSTODIOL (K032794) | Dr. Franz Kohler Chemie GmbH | 2004-04-05 |
| PERFADEX SOLUTION FOR ORGAN PRESERVATION (K000881) | Vitrolife Sweden AB | 2001-03-08 |
| CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS (K991594) | Sangstat Medical Corp. | 1999-08-05 |
Recalls involving this device
No recalls on record reference this clearance.