K934742 is an FDA 510(k) clearance for the SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT. This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on January 24, 1994, 112 days after receiving the submission on October 4, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K934742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1993 |
| Decision Date | January 24, 1994 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DYG — Catheter, Flow Directed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1240 |