# K260839: Protaryx Transseptal  Puncture Device (PTX2-001)

- Pathway: 510(k) (Traditional)
- Applicant: Protaryx Medical, Inc.
- Decided: Apr 10, 2026 after 28 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 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.
- K242076: VersaCross™ RF Wire, Baylis Medical Company (2024) Summary page 5.

## Indications for use
The Protaryx Transseptal Puncture Device is used to introduce various cardiovascular catheters to the heart, including the left side of the heart. The device enables left heart access through a puncture of the atrial septum during a transseptal catheterization procedure.

Source page: https://510kreport.com/device/K260839
Methodology: https://510kreport.com/methodology