The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic 6f Taiga Guiding Catheter.
Device ID | K192296 |
510k Number | K192296 |
Device Name: | Medtronic 6F Taiga Guiding Catheter |
Classification | Catheter, Percutaneous |
Applicant | Medtronic Vascular 37a Cherry Hill Drive Danvers, MA 01923 |
Contact | Colleen Mullins |
Correspondent | Colleen Mullins Medtronic Vascular 37a Cherry Hill Drive Danvers, MA 01923 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-23 |
Decision Date | 2019-09-20 |
Summary: | summary |