# K252083: HOTWIRE™ System RF Generator and Footswitch (optional accessory)

- Pathway: 510(k) (Traditional)
- Applicant: Atraverse Medical, Inc.
- Decided: Aug 12, 2025 after 41 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K013904 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232809: Cross Vascular RF Generator and Footswitch (optional accessory), Cross Vascular, Inc. (2023) Summary page 5.

## Indications for use
The HOTWIRE System RF Generator and Footswitch (optional accessory) is to be used with separately cleared RF puncture devices in cardiovascular transseptal access procedures to create an atrial septal defect.

Source page: https://510kreport.com/device/K252083
Methodology: https://510kreport.com/methodology