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 |