K932208 is an FDA 510(k) clearance for the EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on August 9, 1994, 460 days after receiving the submission on May 6, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K932208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1993 |
| Decision Date | August 09, 1994 |
| Days to Decision | 460 days |
| Submission Type | Traditional |
| 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 |