K896730 is an FDA 510(k) clearance for the SUCTION CATHETER STRAIGHT/COUDE. This device is classified as a Catheters, Suction, Tracheobronchial (Class I - General Controls, product code BSY).
Submitted by Unoplast A/S (Denmark, DK). The FDA issued a Cleared decision on March 30, 1990, 120 days after receiving the submission on November 30, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6810.
| 510(k) Number | K896730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1989 |
| Decision Date | March 30, 1990 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BSY — Catheters, Suction, Tracheobronchial |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.6810 |