K862634 is an FDA 510(k) clearance for the TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 31, 1986, 113 days after receiving the submission on July 10, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K862634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1986 |
| Decision Date | October 31, 1986 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4210 |