K142546 is an FDA 510(k) clearance for the TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath. This device is classified as a Dilator, Vessel, For Percutaneous Catheterization (Class II - Special Controls, product code DRE).
Submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on September 25, 2014, 15 days after receiving the submission on September 10, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1310.
| 510(k) Number | K142546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2014 |
| Decision Date | September 25, 2014 |
| Days to Decision | 15 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 |