K922843 is an FDA 510(k) clearance for the DYNAREX SUCTION CATHETERS & KITS. This device is classified as a Catheters, Suction, Tracheobronchial (Class I - General Controls, product code BSY).
Submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on January 11, 1993, 213 days after receiving the submission on June 12, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6810.
| 510(k) Number | K922843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 1992 |
| Decision Date | January 11, 1993 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSY — Catheters, Suction, Tracheobronchial |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.6810 |