K973237 is an FDA 510(k) clearance for the CSS-CARDIOPLEGIA SAFETY SYSTEM. This device is classified as a Pump, Blood, Cardiopulmonary Bypass, Roller Type (Class II - Special Controls, product code DWB).
Submitted by Medtronic Bio-Medicus, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on April 27, 1998, 242 days after receiving the submission on August 28, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4370.
| 510(k) Number | K973237 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1997 |
| Decision Date | April 27, 1998 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWB — Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4370 |