# K252419: Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)

- Pathway: 510(k) (Traditional)
- Applicant: Atraverse Medical, Inc.
- Decided: Aug 27, 2025 after 26 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
Longest line of descent: 4 generations back to K011727 (2002). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240900: HOTWIRE™ RF Guidewire, Atraverse Medical (2024) Summary page 5.

## Most influential descendants
- K260292: Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) (2026), 0 descendants of its own

## Indications for use
The HOTWIRE is indicated for creation of an atrial septal defect in the heart.

Source page: https://510kreport.com/device/K252419
Methodology: https://510kreport.com/methodology