# K061416: Selectsite  C304 Deflectable Catheter System, Models C304-S59, C304-L69, C304-XS59 & C304-XL74

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Oct 25, 2006 after 156 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: 6 generations back to K893658 (1989). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033989: Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69, Medtronic Inc. Cardiac Rhythm Management (2004) Summary page 2.
- K032312: Attain 6226DEF Deflectable Catheter Delivery System, Medtronic Vascular (2003) Summary page 2.

## Most influential descendants
- K183493: SelectSite C304-HIS Deflectable Catheter System (2019), 0 descendants of its own

## Indications for use
The deflectable catheter 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/K061416
Methodology: https://510kreport.com/methodology