K894168 is an FDA 510(k) clearance for the SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F. 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 November 27, 1989, 165 days after receiving the submission on June 15, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K894168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1989 |
| Decision Date | November 27, 1989 |
| Days to Decision | 165 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 |