# K113773: ST Jude Medical, IS4 Flushing/Funneling Tool

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Jan 18, 2012 after 27 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P030054 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P030054: ST Jude Medical Epic HF System, Abbott Medical (2004) Summary page 1.

## Indications for use
The IS4 Flushing/Funneling Tool is to provide a means of flushing the lead and facilitate the insertion of either a guidewire or stylet into the connector pin of the over the wire left heart lead with an 1S4 connector

Source page: https://510kreport.com/device/K113773
Methodology: https://510kreport.com/methodology