The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Tightrail Rotating Dilator Sheath/tightrail Mini Dilator Sheath.
| Device ID | K142546 |
| 510k Number | K142546 |
| Device Name: | TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | SPECTRANETICS, INC. 9965 FEDERAL DRIVE Colorado Springs, CO 80921 |
| Contact | Christopher Mclellan |
| Correspondent | Christopher Mclellan SPECTRANETICS, INC. 9965 FEDERAL DRIVE Colorado Springs, CO 80921 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-10 |
| Decision Date | 2014-09-25 |
| Summary: | summary |