Company
SPS Sterilization, Inc
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
15recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2018 | SPS Sterilization, Inc Vascular Solutions Venture Rx Catheter, 6F, resterilized. Terminated |
DQY | K042910 |
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized. Terminated |
JCT | K152842 |
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized. Terminated |
JCT | K152842 |
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized. Terminated |
MQR | K042065 |
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized. Terminated |
JCT | K152842 |
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized. Terminated |
JCT | K152842 |
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized. Terminated |
JCT | K152842 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized. Terminated |
DQR | K073559 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. Terminated |
DWF | K140208 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. Terminated |
DWF | K140208 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized. Terminated |
DWF | K120072 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized. Terminated |
DWF | K120072 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized. Terminated |
DWF | K120072 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. Terminated |
DWF | K123370 |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. Terminated |
DWF | K123370 |