# K242076: VersaCross™ RF Wire

- Pathway: 510(k) (Special)
- Applicant: Baylis Medical Company
- Decided: Nov 1, 2024 after 108 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: 3 generations back to K011727 (2002). 5 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K150709: ProTrack RF Anchor Wire, Baylis Medical Company, Inc. (2015) Summary page 6.

## Most influential descendants
- K260839: Protaryx Transseptal  Puncture Device (PTX2-001) (2026), 0 descendants of its own
- K253799: SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) (2026), 0 descendants of its own

## Indications for use
The VersaCross™ RF Wire is indicated for creation of an atrial septal defect in the heart.

Source page: https://510kreport.com/device/K242076
Methodology: https://510kreport.com/methodology