SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
FDA 510(k) clearance K091656 · decided 2010-03-11
Clearance details
- K-number
- K091656
- Device name
- SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
- Applicant
- Organ Recovery Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-09
- Decision date
- 2010-03-11
- Days to decision
- 275 days
- Clearance type
- Traditional
- Product code
- KDL
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Des Plaines, IL, US
- Third-party review
- No
- Expedited review
- No
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| PERF-GEN PULSATILE PERFUSION SOLUTION (K121736) | Waters Medical Systems, LLC | 2013-08-16 |
| BEL-GEN COLD STORAGE SOLUTION (K121618) | Waters Medical Systems, LLC | 2013-06-14 |
| CUSTODIOL (K043461) | Dr. Franz Kohler Chemie GmbH | 2005-02-28 |
| CUSTODIOL HTK SOLUTION (K020924) | Dr. Franz Kohler Chemie GmbH | 2003-01-06 |
| GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET (K955497) | Cobe Renal Care, Inc. | 1997-09-25 |
| VIASPAN (BELZER UW - CSS) (K944866) | The Dupont Merck Pharmaceutical Co. | 1996-04-22 |
Recalls involving this device
No recalls on record reference this clearance.