The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Tightrail Guardian Motorized Dilator Sheath.
| Device ID | K212784 |
| 510k Number | K212784 |
| Device Name: | TightRail Guardian Motorized Dilator Sheath |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | Spectranetics, Inc. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Jordan Baum |
| Correspondent | Jordan Baum 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 | 2021-09-01 |
| Decision Date | 2022-08-24 |