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 |