K150360 is an FDA 510(k) clearance for the TightRail Rotating Dilator Sheath, TightRail Mini Rotating 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 March 4, 2015, 20 days after receiving the submission on February 12, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1310.
| 510(k) Number | K150360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2015 |
| Decision Date | March 04, 2015 |
| Days to Decision | 20 days |
| Submission Type | Special |
| 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 |