# K061480: Attain 6227DEF Deflectable Catheter Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Ireland
- Decided: Aug 21, 2006 after 83 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: 5 generations back to K893658 (1989). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032312: Attain 6226DEF Deflectable Catheter Delivery System, Medtronic Vascular (2003) Summary page 2.

## Indications for use
The deflectable catheter delivery system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

Source page: https://510kreport.com/device/K061480
Methodology: https://510kreport.com/methodology