TIGHTRAIL MINI
Dilator, Vessel, For Percutaneous Catheterization
SPECTRANETICS, INC.
The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Tightrail Mini.
Pre-market Notification Details
| Device ID | K141131 |
| 510k Number | K141131 |
| Device Name: | TIGHTRAIL MINI |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-01 |
| Decision Date | 2014-05-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M204540011AB0 | K141131 | 000 |
| M204540009AB0 | K141131 | 000 |
| M2045400110 | K141131 | 000 |
| M2045400090 | K141131 | 000 |
Trademark Results [TIGHTRAIL MINI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TIGHTRAIL MINI 86235187 4729002 Live/Registered |
The Spectranetics Corporation 2014-03-28 |
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