# K032312: Attain 6226DEF Deflectable Catheter Delivery System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Oct 21, 2003 after 85 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: 4 generations back to K893658 (1989). 36 ancestors in all.
37 later devices descend from it; 3 cite it directly.
5 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013517: 10600 Deflectable Catheter System, Model 10600, Medtronic Vascular (2002)
- K010128: Cook Vascular Peel-Away Hemostasis Valve, Cook Vascular, Inc. (2002) Summary page 5.
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218, Medtronic Vascular (2001)
- (no number) Medtronic 6228SLT Universal Slitter: named in the summary without a submission number

## Most influential descendants
- K033989: Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 (2004), 35 descendants of its own
- K072313: Amplatzer Torqvue Delivery System (2007), 30 descendants of its own
- K083214: Amplatzer Torqvue  45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100 (2009), 10 descendants of its own
- K080757: Amplatzer Torqvue Low Profile Delivery System (2008), 7 descendants of its own
- K131063: Amplatzer Torq Vue LP Delivery System (2013), 5 descendants of its own

## Indications for use
The deflectable catheter delivery system is indicated to provide a pathway through 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/K032312
Methodology: https://510kreport.com/methodology