# K083422: 6F Taiga Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Feb 6, 2009 after 79 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981198 (1998). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042489: 6F Z4 Guide Catheter, Medtronic Vascular (2004) Summary page 1.

## Most influential descendants
- K192296: Medtronic 6F Taiga Guiding Catheter (2019), 0 descendants of its own

## Recalls of this device
- Sep 26, 2017 · Class I · Z-1207-2018: Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.

## Indications for use
The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

Source page: https://510kreport.com/device/K083422
Methodology: https://510kreport.com/methodology