# K183493: SelectSite C304-HIS Deflectable Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Mar 15, 2019 after 88 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: 7 generations back to K893658 (1989). 39 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K061416: Selectsite  C304 Deflectable Catheter System, Models C304-S59, C304-L69, C304-XS59 & C304-XL74, Medtronic Vascular (2006) Summary page 5.

## Recalls of this device
- Apr 20, 2022 · Class II · Z-1206-2022: The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.

## Indications for use
The device 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/K183493
Methodology: https://510kreport.com/methodology