InTRAkit
Introducer, Catheter
Medtronic Vascular
The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Intrakit.
Pre-market Notification Details
| Device ID | K162097 |
| 510k Number | K162097 |
| Device Name: | InTRAkit |
| Classification | Introducer, Catheter |
| Applicant | Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923 |
| Contact | Nisarg Shah |
| Correspondent | Nisarg Shah Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-29 |
| Decision Date | 2016-11-17 |
| Summary: | summary |
Trademark Results [InTRAkit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTRAKIT 86213139 5360244 Live/Registered |
Medtronic Vascular, Inc. 2014-03-06 |
 INTRAKIT 77698169 not registered Dead/Abandoned |
Solar Technologies, Inc. 2009-03-24 |
 INTRAKIT 75500372 not registered Dead/Abandoned |
Internet Software Technologies, L.L.C. 1998-06-11 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.