K884913 is an FDA 510(k) clearance for the MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM). This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Merit Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 18, 1989, 141 days after receiving the submission on November 28, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K884913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1988 |
| Decision Date | April 18, 1989 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXT — Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |