The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Intrakit.
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 |
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 |