K922254 is an FDA 510(k) clearance for the LUKENS 2-0 BRAIDED SILK SUTURES. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on September 1, 1992, 203 days after receiving the submission on February 11, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K922254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1992 |
| Decision Date | September 01, 1992 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |