# K051670: RF Tunneler Wire

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Mar 30, 2006 after 281 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: 7 generations back to K890505 (1989). 27 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010265: Baylis Medical RF Perforation Probe, Model RFP-265, Baylis Medical Co., Inc. (2001) Summary page 1.
- K031842: Safe-Cross Radio Frequency Total Occlusion Crossing System, Intra Luminal Therapeutics, Inc. (2003) Summary page 1.
- K040067: Clirpath Excimer Laser Catheter, Spectranetics Corp. (2004) Summary page 1.

## Most influential descendants
- K101615: Powerwire Radiofrequency Guidewire (2010), 2 descendants of its own
- K232562: PowerWire Radiofrequency Guidewire Kit (2024), 1 descendant of its own
- K101599: RVT Cto Device (2011), 1 descendant of its own
- K251158: PowerWire® 14 Radiofrequency Guidewire Kit (2025), 0 descendants of its own
- K140288: Truepath Cto Device (2014), 0 descendants of its own

## Indications for use
The RF Tunneler Wire is intended to create a channel in tofally occluded peripheral vessels 3 mm or greater.

Source page: https://510kreport.com/device/K051670
Methodology: https://510kreport.com/methodology