K910204 is an FDA 510(k) clearance for the SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM). This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on April 24, 1991, 98 days after receiving the submission on January 16, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K910204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1991 |
| Decision Date | April 24, 1991 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |