K061527 is an FDA 510(k) clearance for the CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING. This device is classified as a Reservoir, Blood, Cardiopulmonary Bypass (Class II - Special Controls, product code DTN).
Submitted by Sorin Group Italia S.R.L. (Waltham, US). The FDA issued a Cleared decision on June 27, 2006, 25 days after receiving the submission on June 2, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K061527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2006 |
| Decision Date | June 27, 2006 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4400 |