# K191546: Epicardial Access System

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: Aug 2, 2019 after 51 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
Longest line of descent: 1 generation back to K111943 (2011). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111943: Agills PF Delivery System, St. Jude Medical, Cardiac Rhythm Management Divisi (2011) Summary page 4.

## Most influential descendants
- K213582: Epicardial Access System (2022), 0 descendants of its own

## Indications for use
The Epicardial Access 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/K191546
Methodology: https://510kreport.com/methodology