K897197 is an FDA 510(k) clearance for the ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.. 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 March 19, 1990, 80 days after receiving the submission on December 29, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4290.
| 510(k) Number | K897197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1989 |
| Decision Date | March 19, 1990 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4290 |