Servator C SALF Solution
FDA 510(k) clearance K190063 · decided 2019-08-14
Clearance details
- K-number
- K190063
- Device name
- Servator C SALF Solution
- Applicant
- S.A.L.F. Spa
- Decision
- Substantially Equivalent
- Date received
- 2019-01-15
- Decision date
- 2019-08-14
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- MSB
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cenate Sotto, IT
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch S.A.L.F. Spa
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OCS Lung Donor Flush Set (K222535) | TransMedics, Inc. | 2022-11-18 |
| OCS Lung Solution (K211314) | TransMedics, Inc. | 2021-07-29 |
| Paragonix SherpaPak Cardiac Transport System (K182735) | Paragonix Technologies | 2018-10-19 |
| SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (K180194) | Paragonix Technologies, Inc. | 2018-03-30 |
| 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 LUNG PRESERVATION (K022730) | Vitrolife AB | 2003-10-27 |
| 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.