K172487 is an FDA 510(k) clearance for the Coaxial Dilator Set (Micro-Introducer). This device is classified as a Dilator, Vessel, For Percutaneous Catheterization (Class II - Special Controls, product code DRE).
Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on October 16, 2017, 60 days after receiving the submission on August 17, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1310.
| 510(k) Number | K172487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | August 17, 2017 |
| Decision Date | October 16, 2017 |
| Days to Decision | 60 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 |