# K162418: Pioneer Plus Catheter

- Pathway: 510(k) (Special)
- Applicant: Philips Volcano
- Decided: Dec 2, 2016 after 94 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: 6 generations back to K001577 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101777: Pioneer Plus Catheter, Model Plus 120, Medtronic Vascular (2010) Summary page 4.

## Indications for use
The Pioneer Plus catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus catheter also provides an intraluminal cross-sectional ultrasound image of the area of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTA, stent, etc.). The Pioneer Plus catheter is not indicated for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K162418
Methodology: https://510kreport.com/methodology