# K012130: Attain LDS 6216 Left-Heart Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Aug 28, 2001 after 50 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: 2 generations back to K893658 (1989). 7 ancestors in all.
97 later devices descend from it; 6 cite it directly.
5 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950490: Medtronic GC IV Coronary Guiding Catheter, Medtronics Interventional Vascular (1995) Summary page 2.
- K003731: Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve, Thomas Medical Products, Inc. (2001) Summary page 2.
- K950179: Medtronic (R) GC Iii Coronary Guiding Catheter, Medtronics Interventional Vascular (1995) Summary page 2.
- K990707: Medtronic 5F & 9F Zuma Guiding Catheters, Medtronics Interventional Vascular (1999) Summary page 2.
- K965167: Percutaneous Venous Introducer 10264, Medamicus, Inc. (1997) Summary page 2.

## Most influential descendants
- K013517: 10600 Deflectable Catheter System, Model 10600 (2002), 80 descendants of its own
- K032312: Attain 6226DEF Deflectable Catheter Delivery System (2003), 37 descendants of its own
- K033989: Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 (2004), 35 descendants of its own
- K021587: Attain LDS 6216A Left-Heart Delivery System, Model 6216A (2002), 31 descendants of its own
- K072313: Amplatzer Torqvue Delivery System (2007), 30 descendants of its own

## Indications for use
The Attain™ LDS 6216 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/K012130
Methodology: https://510kreport.com/methodology