# K203459: SafeCross Transseptal Puncture and Introducer (TSP/I) System

- Pathway: 510(k) (Traditional)
- Applicant: East End Medical I, LLC
- Decided: Jul 6, 2021 after 224 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: 4 generations back to K964518 (1997). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081645: Agilis NXT Steerable Introducer, Model G408324, St Jude Medical (2008) Summary page 4.
- K073326: NRG Transseptal Needle, Baylis Medical Co., Inc. (2008) Summary page 4.

## Most influential descendants
- K260839: Protaryx Transseptal  Puncture Device (PTX2-001) (2026), 0 descendants of its own
- K240600: SafeCross Vascular Introducer System (4001) (2024), 0 descendants of its own

## Indications for use
The SafeCross Transseptal Puncture Device and Introducer (TSP/I) System is used to introduce various cardiovascular catheters to the heart, including the left side of the heart. The system enables left heart access through a puncture of the atrial septum during a transseptal catheterization procedure. In addition, the device can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions.

Source page: https://510kreport.com/device/K203459
Methodology: https://510kreport.com/methodology