# K200721: Agilis HisPro Steerable Catheter With Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Abbott (St. Jude Medical)
- Decided: Jun 3, 2020 after 76 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). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 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.
- K052575: Luminary Cannulator Bideflectable Catheter with Lumen, St Jude Medical (2006) Summary page 5.

## Indications for use
The Agilis HisPro Steerable Catheter With Electrodes is indicated to provide a pathway for delivery and support of transvenous devices within the chambers and vasculature of the heart and can be used for electrogram recording and stimulation.

Source page: https://510kreport.com/device/K200721
Methodology: https://510kreport.com/methodology