K091584 is an FDA 510(k) clearance for the MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE. This device is classified as a Dilator, Vessel, For Percutaneous Catheterization (Class II - Special Controls, product code DRE).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 9, 2009, 129 days after receiving the submission on June 2, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1310.
| 510(k) Number | K091584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2009 |
| Decision Date | October 09, 2009 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRE — Dilator, Vessel, For Percutaneous Catheterization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1310 |