The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Tightrail Sub-c Rotating Dilator Sheath.
| Device ID | K161333 |
| 510k Number | K161333 |
| Device Name: | TightRail Sub-C Rotating Dilator Sheath |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | Spectranetics, Inc. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Stephanie Byrum |
| Correspondent | Stephanie Byrum 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 | 2016-05-12 |
| Decision Date | 2016-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813132022808 | K161333 | 000 |
| 00813132022792 | K161333 | 000 |
| 00813132022785 | K161333 | 000 |