K113667 is an FDA 510(k) clearance for the CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING. This device is classified as a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II - Special Controls, product code DTL).
Submitted by Edwards Lifesciences, LLC (Draper, US). The FDA issued a Cleared decision on January 12, 2012, 30 days after receiving the submission on December 13, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4290.
| 510(k) Number | K113667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2011 |
| Decision Date | January 12, 2012 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4290 |