# K232562: PowerWire Radiofrequency Guidewire Kit

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Technologies, Inc.
- Decided: Feb 28, 2024 after 188 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K890505 (1989). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101615: Powerwire Radiofrequency Guidewire, Baylis Medical Co., Inc. (2010) Summary page 5.

## Most influential descendants
- K251158: PowerWire® 14 Radiofrequency Guidewire Kit (2025), 0 descendants of its own

## Indications for use
The PowerWire Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater, including vessels with stents.

Source page: https://510kreport.com/device/K232562
Methodology: https://510kreport.com/methodology