K942391 is an FDA 510(k) clearance for the BRAUN MANIFOLD. This device is classified as a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II - Special Controls, product code DTL).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on June 21, 1995, 398 days after receiving the submission on May 19, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4290.
| 510(k) Number | K942391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1994 |
| Decision Date | June 21, 1995 |
| Days to Decision | 398 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 |