Submission Details
| 510(k) Number | K161333 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 12, 2016 |
| Decision Date | July 08, 2016 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
TightRail Sub-C Rotating Dilator Sheath
Jul 2016
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K161333 is an FDA 510(k) clearance for the TightRail Sub-C 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 July 8, 2016, 57 days after receiving the submission on May 12, 2016. 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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