Submission Details
| 510(k) Number | K150360 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
Mar 2015
Decision
20d
Days
Class 2
Risk
About This 510(k) Submission
K150360 is an FDA 510(k) clearance for the TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath, 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 review panel. Regulated under 21 CFR 870.1310.
Device Classification
| Product Code | DRE — Dilator, Vessel, For Percutaneous Catheterization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1310 |
Manufacturer
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