# K232809: Cross Vascular RF Generator and Footswitch (optional accessory)

- Pathway: 510(k) (Traditional)
- Applicant: Cross Vascular, Inc.
- Decided: Oct 12, 2023 after 30 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: 2 generations back to K013904 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122278: Baylis Medical Company Radiofrequency Perforation Generator, Baylis Medical Company, Inc. (2012) Summary page 5.

## Most influential descendants
- K252083: HOTWIRE™ System RF Generator and Footswitch (optional accessory) (2025), 0 descendants of its own

## Indications for use
The Cross Vascular RF Generator and Footswitch (optional accessory) are 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/K232809
Methodology: https://510kreport.com/methodology