K893435 is an FDA 510(k) clearance for the SILICONE FLOW-DIRECTED THERMODILUTION CATHETER. This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by Cathlab Corp. (Tustin, US). The FDA issued a Cleared decision on September 26, 1989, 147 days after receiving the submission on May 2, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K893435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1989 |
| Decision Date | September 26, 1989 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DYG — Catheter, Flow Directed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1240 |