The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for 6f Taiga Guiding Catheter.
Device ID | K083422 |
510k Number | K083422 |
Device Name: | 6F TAIGA GUIDING CATHETER |
Classification | Catheter, Percutaneous |
Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DRIVE Danvers, MA 01923 |
Contact | Vic Zhang |
Correspondent | Vic Zhang 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 | 2008-11-19 |
Decision Date | 2009-02-06 |
Summary: | summary |