K791183 is an FDA 510(k) clearance for the SWAN-GANZ FLOW-DIRECTED CATHETER. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on July 12, 1979, 17 days after receiving the submission on June 25, 1979.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K791183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1979 |
| Decision Date | July 12, 1979 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | LDF — Electrode, Pacemaker, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3680 |