# K111943: Agills PF Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
- Decided: Sep 29, 2011 after 83 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) St. Jude Medical Fast Cath Introducer: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K402049: St Jude Medical Agilis NxT Steerable Introducer. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K233959: EPi-Ease Epicardial Access Device (EAS) (2024), 1 descendant of its own
- K210185: CardioCurve Steerable Sheath (2021), 1 descendant of its own
- K191546: Epicardial Access System (2019), 1 descendant of its own
- K142245: EpiAccess System (2014), 1 descendant of its own
- K243954: PeriCross™ Epicardial Access Kit (2025), 0 descendants of its own

## Indications for use
The AgilisiTM PF Introducer System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies

Source page: https://510kreport.com/device/K111943
Methodology: https://510kreport.com/methodology