# K240600: SafeCross Vascular Introducer System (4001)

- Pathway: 510(k) (Special)
- Applicant: East End Medical I, LLC
- Decided: Sep 6, 2024 after 186 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: 5 generations back to K964518 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203459: SafeCross Transseptal Puncture and Introducer (TSP/I) System, East End Medical I, LLC (2021) Summary page 5.

## Indications for use
The SafeCross Vascular System is a Steerable Balloon Introducer System with Access Dilator used for introducing various cardiovascular catheters into the vasculature including the heart. In addition, the device can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions.

Source page: https://510kreport.com/device/K240600
Methodology: https://510kreport.com/methodology