Submission Details
| 510(k) Number | K904785 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 22, 1990 |
| Decision Date | March 06, 1991 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Cleared
Traditional
K904785 - CRI CYNOSAR CATHETER
(FDA 510(k) Clearance)
Mar 1991
Decision
135d
Days
Class 2
Risk
K904785 is an FDA 510(k) clearance for the CRI CYNOSAR CATHETER, 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 March 6, 1991, 135 days after receiving the submission on October 22, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.
Device Classification
| Product Code | DRA — Catheter, Steerable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1280 |
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