K911884 is an FDA 510(k) clearance for the ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES. 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 July 5, 1994, 1163 days after receiving the submission on April 29, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4290.
| 510(k) Number | K911884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1991 |
| Decision Date | July 05, 1994 |
| Days to Decision | 1163 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 |