K012898 is an FDA 510(k) clearance for the MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM. This device is classified as a Heat-exchanger, Cardiopulmonary Bypass (Class II - Special Controls, product code DTR).
Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on September 17, 2001, 19 days after receiving the submission on August 29, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4240.
| 510(k) Number | K012898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2001 |
| Decision Date | September 17, 2001 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTR — Heat-exchanger, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4240 |