# K021587: Attain LDS 6216A Left-Heart Delivery System, Model 6216A

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: May 30, 2002 after 15 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K893658 (1989). 31 ancestors in all.
31 later devices descend from it; 5 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012130: Attain LDS 6216 Left-Heart Delivery System, Medtronic Vascular (2001) Summary page 2.
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218, Medtronic Vascular (2001) Summary page 2.
- (no number) Guide Wire Clip: named in the summary without a submission number

## Most influential descendants
- K031211: Attain Prevail Steerable Catheter Set, Model 6228CTH (2003), 29 descendants of its own
- K042194: Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery (2004), 17 descendants of its own
- K053431: Attain Select II 6248DEL Delivery Catheter System (2006), 14 descendants of its own
- K024032: Attain 6216A-MP Multi-Purpose Guide Catheter for Left-Heart Delivery (2002), 14 descendants of its own
- K080428: Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters for Left Heart Delivery (2008), 13 descendants of its own

## Recalls of this device
- Aug 27, 2008 · Not classified · Z-2472-2008: Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve pac

## Indications for use
The Attain™ LDS 6216A Left-heart delivery system is intended 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/K021587
Methodology: https://510kreport.com/methodology