# K170831: EpiAccess System

- Pathway: 510(k) (Special)
- Applicant: Epiep, Inc.
- Decided: May 9, 2017 after 50 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: 7 generations back to K831506 (1983). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142245: EpiAccess System, Epiep, Inc. (2014) Summary page 4.

## Indications for use
The EpiAccess System with introducer needle and integrated needle tip pressure transducer is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in electrophysiology procedures in adult patients.

Source page: https://510kreport.com/device/K170831
Methodology: https://510kreport.com/methodology