# K140288: Truepath Cto Device

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Apr 16, 2014 after 70 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). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101599: RVT Cto Device, Revascular Therapeutics, Inc. (2011) Summary page 2.

## Indications for use
The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. Contraindications: The device is contraindicated for use in carotid arteries. The TruePath Extension Wire is designed to extend the TruePath OTO Device so that a catheter can be exchanged for another catheter.

Source page: https://510kreport.com/device/K140288
Methodology: https://510kreport.com/methodology