# K082670: Modification to: Attain Prevail 6228CTH80 Steerable Catheter Set

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Dec 4, 2008 after 80 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K893658 (1989). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031211: Attain Prevail Steerable Catheter Set, Model 6228CTH, Medtronic Vascular (2003) Summary page 1.
- K032622: Attain Prevail Left Heart Delivery System Moddel, 6228SYS, Medtronic Vascular (2003) Summary page 1.

## Indications for use
The steerable catheter set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

Source page: https://510kreport.com/device/K082670
Methodology: https://510kreport.com/methodology