# K032622: Attain Prevail Left Heart Delivery System Moddel, 6228SYS

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Sep 3, 2003 after 8 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). 42 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 48 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)
- K021589: Attain Access 6218A Left-Heart Delivery System, Model 6218, Medtronic Vascular (2002)
- (no number) Introducer Valve, Model 6228VAL: named in the summary without a submission number

## Most influential descendants
- K042381: Coronary Sinus Visualization System, Model CSVS5508 (2004), 3 descendants of its own
- K050808: Coronary Sinus Access Kit, Model KCS8F-01 (2005), 1 descendant of its own
- K082670: Modification to: Attain Prevail 6228CTH80 Steerable Catheter Set (2008), 0 descendants of its own
- K070051: Acumen Insight Endocardial Visualization System (2007), 0 descendants of its own
- K062340: Cardiooptics Augmentative Cardiac Optical Imaging System (2006), 0 descendants of its own

## Indications for use
The Attain Prevail Left Heart Delivery System 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/K032622
Methodology: https://510kreport.com/methodology