K914208 is an FDA 510(k) clearance for the MERIT DISPOSAL DEPOT(TM). This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Merit Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 18, 1991, 90 days after receiving the submission on September 19, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K914208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1991 |
| Decision Date | December 18, 1991 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |