K810023 is an FDA 510(k) clearance for the HYDROPHILIC COATED CATHETER. This device is classified as a Catheters, Suction, Tracheobronchial (Class I - General Controls, product code BSY).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on February 6, 1981, 32 days after receiving the submission on January 5, 1981.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6810.
| 510(k) Number | K810023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1981 |
| Decision Date | February 06, 1981 |
| Days to Decision | 32 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 |