# K031949: Toronto RF Septostomy Catheter, Model TSC-50-75

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Dec 10, 2003 after 169 days
- Product code: DXF (Catheter, Septostomy)
- Device class: 2
- Regulation: 21 CFR 870.5175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K073326: NRG Transseptal Needle (2008), 16 descendants of its own
- K150709: ProTrack RF Anchor Wire (2015), 7 descendants of its own
- K232852: Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable (2023), 3 descendants of its own
- K242076: VersaCross™ RF Wire (2024), 2 descendants of its own
- K241414: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,  CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) (2024), 2 descendants of its own

## Indications for use
Creation of an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.

Source page: https://510kreport.com/device/K031949
Methodology: https://510kreport.com/methodology