K951566 is an FDA 510(k) clearance for the SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]. 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 November 27, 1995, 237 days after receiving the submission on April 4, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K951566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1995 |
| Decision Date | November 27, 1995 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYG — Catheter, Flow Directed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1240 |