# K243954: PeriCross™ Epicardial Access Kit

- Pathway: 510(k) (Traditional)
- Applicant: Circa Scientific, Inc.
- Decided: Apr 24, 2025 after 122 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 K031691 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K031691: Merit Mak (Mini Access Kit), Merit Medical Systems, Inc. (2003) Summary page 5.

## Indications for use
The PeriCross™ Epicardial Access Kit is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies in adult patients.

Source page: https://510kreport.com/device/K243954
Methodology: https://510kreport.com/methodology