# K251158: PowerWire® 14 Radiofrequency Guidewire Kit

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Technologies, Inc.
- Decided: Sep 11, 2025 after 149 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: 10 generations back to K890505 (1989). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232562: PowerWire Radiofrequency Guidewire Kit, Baylis Medical Technologies, Inc. (2024) Summary page 5.

## Indications for use
The PowerWire® 14 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/K251158
Methodology: https://510kreport.com/methodology