# K181088: TSP Crosser Transseptal Access System

- Pathway: 510(k) (Traditional)
- Applicant: Transseptal Solutions, Ltd.
- Decided: Sep 28, 2018 after 156 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070417: Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984, St Jude Medical (2007) Summary page 4.

## Indications for use
The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers.

Source page: https://510kreport.com/device/K181088
Methodology: https://510kreport.com/methodology