# K052575: Luminary Cannulator Bideflectable Catheter with Lumen

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Jan 19, 2006 after 122 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
Longest line of descent: 5 generations back to K893658 (1989). 43 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040165: Reflexion Cannulator Steerable Electrophysiology Catheter with Lumen, Model 402805, St Jude Medical (2004) Summary page 1.
- K031211: Attain Prevail Steerable Catheter Set, Model 6228CTH, Medtronic Vascular (2003) Summary page 3.

## Most influential descendants
- 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 Luminary CannulatorTM Bideflectable Catheter with Lumen is indicated to provide a pathway for delivery and support of transvenous devices and fluids to the coronary sinus and coronary vasculature of the heart. The Luminary CannulatorTM Bideflectable Catheter with Lumen can also 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/K052575
Methodology: https://510kreport.com/methodology