# K221163: Tunnel Crossing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Tractus Vascular, LLC
- Decided: Jan 19, 2023 after 272 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: 11 generations back to K931794 (1994). 59 ancestors in all.
No later device cites it as a predicate yet.
3 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120533: Bigboss Catheters Mantatay Catheter Mantaray Guidewires, Bridgepoint Medical (2012) Summary page 4.

## Indications for use
The Tunnel CC is intended to be used with a guidewire to access discrete regions of the peripheral vasculature and to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

Source page: https://510kreport.com/device/K221163
Methodology: https://510kreport.com/methodology