K910429 is an FDA 510(k) clearance for the SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER. This device is classified as a Transducer, Pressure, Catheter Tip (Class II - Special Controls, product code DXO).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on July 11, 1991, 160 days after receiving the submission on February 1, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.
| 510(k) Number | K910429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1991 |
| Decision Date | July 11, 1991 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXO — Transducer, Pressure, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2870 |