K190175 is an FDA 510(k) clearance for the S-MAK XL. 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 April 10, 2019, 68 days after receiving the submission on February 1, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1310.
| 510(k) Number | K190175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2019 |
| Decision Date | April 10, 2019 |
| Days to Decision | 68 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 |