# K040165: Reflexion Cannulator Steerable Electrophysiology Catheter with Lumen, Model 402805

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: May 12, 2004 after 107 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 6F Reflexion Bidirectional Electrophysiology Catheter: named in the summary without a submission number

## Most influential descendants
- K052575: Luminary Cannulator Bideflectable Catheter with Lumen (2006), 4 descendants of its own
- K103083: Agilis ES Steerable Introducer (2011), 2 descendants of its own
- K171557: AcQRef Introducer Sheath (2018), 1 descendant of its own
- K200721: Agilis HisPro Steerable Catheter With Electrodes (2020), 0 descendants of its own
- K192106: AcQRef Introducer Sheath (2019), 0 descendants of its own

## Indications for use
The St. Jude Medical (SJM) Reflexion Cannulator T M Steerable Electrophysiology Catheter with Lumen can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites when minimizing blood loss is essential.

Source page: https://510kreport.com/device/K040165
Methodology: https://510kreport.com/methodology