K100319 is an FDA 510(k) clearance for the MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R. This device is classified as a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II - Special Controls, product code DTL).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on April 28, 2010, 83 days after receiving the submission on February 4, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4290.
| 510(k) Number | K100319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2010 |
| Decision Date | April 28, 2010 |
| Days to Decision | 83 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 |