K915301 is an FDA 510(k) clearance for the ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK. This device is classified as a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II - Special Controls, product code DTL).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on December 11, 1992, 386 days after receiving the submission on November 21, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4290.
| 510(k) Number | K915301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1991 |
| Decision Date | December 11, 1992 |
| Days to Decision | 386 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4290 |