K133293 is an FDA 510(k) clearance for the 15 FR. TANDEMHEART ARTERIAL CANNULA. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 12, 2014, 110 days after receiving the submission on October 25, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K133293 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 2013 |
| Decision Date | February 12, 2014 |
| Days to Decision | 110 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4210 |