# K112917: Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery System, Attain 6216A and 6218A Guid

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Oct 27, 2011 after 24 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: 9 generations back to K893658 (1989). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021589: Attain Access 6218A Left-Heart Delivery System, Model 6218, Medtronic Vascular (2002) Summary page 3.
- K021587: Attain LDS 6216A Left-Heart Delivery System, Model 6216A, Medtronic Vascular (2002) Summary page 3.
- K024035: Attain 6218A-AM Amplatz Guide Catheter for Left-Heart Delivery, Medtronic Vascular (2002) Summary page 3.
- K024032: Attain 6216A-MP Multi-Purpose Guide Catheter for Left-Heart Delivery, Medtronic Vascular (2002) Summary page 3.
- K090659: Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart Delivery, Medtronic, Inc. (2009) Summary page 3.

## Indications for use
The Attain 6216A/6218A Product Family 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/K112917
Methodology: https://510kreport.com/methodology