K900320 is an FDA 510(k) clearance for the CRI CYNOSAR CATHETER. This device is classified as a Catheter, Steerable (Class II - Special Controls, product code DRA).
Submitted by Catheter Research C/O Burditt, Bowles & Radzius (Indianapolis, US). The FDA issued a Cleared decision on September 14, 1990, 234 days after receiving the submission on January 23, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1280.
| 510(k) Number | K900320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1990 |
| Decision Date | September 14, 1990 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRA — Catheter, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1280 |