Company ยท US
Preservation Solutions, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2015. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2015 | K151728 | CoStorSol plus G Preservation Solutions, Inc. | KDN |
| Jun 17, 2009 | K091245 | COSTORSOL Preservation Solutions, Inc. | KDN |
| Jan 21, 2009 | K083453 | COSTORSOL Preservation Solutions, Inc. | KDN |
| Aug 8, 2008 | K080432 | MAPERSOL Preservation Solutions, Inc. | KDN |
| Jul 3, 2008 | K073693 | COSTORSOL Preservation Solutions, Inc. | KDN |
| Oct 9, 2002 | K022826 | CLEAR-IT ANTI-FOG, MODEL PS003 Preservation Solutions, Inc. | OCT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2018 | Preservation Solutions, Inc. Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002.
Intended for the hypothermic flushing and Terminated |
KDN | K073693 |
| Nov 22, 2010 | Preservation Solutions Inc Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., El Terminated |
KDN | K073693 |