K001063 is an FDA 510(k) clearance for the SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7. This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on July 7, 2000, 95 days after receiving the submission on April 3, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K001063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2000 |
| Decision Date | July 07, 2000 |
| Days to Decision | 95 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 |