# K101615: Powerwire Radiofrequency Guidewire

- Pathway: 510(k) (Special)
- Applicant: Baylis Medical Co., Inc.
- Decided: Jul 28, 2010 after 49 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: 8 generations back to K890505 (1989). 28 ancestors in all.
2 later devices descend 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)
- K051670: RF Tunneler Wire, Baylis Medical Co., Inc. (2006) Summary page 1.

## Most influential descendants
- K232562: PowerWire Radiofrequency Guidewire Kit (2024), 1 descendant of its own
- K251158: PowerWire® 14 Radiofrequency Guidewire Kit (2025), 0 descendants of its own

## Indications for use
The Power Wire Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater.

Source page: https://510kreport.com/device/K101615
Methodology: https://510kreport.com/methodology