K924452 is an FDA 510(k) clearance for the SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER. 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 October 29, 1993, 422 days after receiving the submission on September 2, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K924452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1992 |
| Decision Date | October 29, 1993 |
| Days to Decision | 422 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 |