K921851 is an FDA 510(k) clearance for the 4 SURE TM SUCTION CATHETERS & KITS. This device is classified as a Catheters, Suction, Tracheobronchial (Class I - General Controls, product code BSY).
Submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on July 7, 1993, 446 days after receiving the submission on April 17, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6810.
| 510(k) Number | K921851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | April 17, 1992 |
| Decision Date | July 07, 1993 |
| Days to Decision | 446 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BSY — Catheters, Suction, Tracheobronchial |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.6810 |