# K081804: Pioneer Plus Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Aug 5, 2008 after 40 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001577 (2001). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072155: Pioneer Catheter, Medtronic, Inc. (2007)

## Most influential descendants
- K101777: Pioneer Plus Catheter, Model Plus 120 (2010), 1 descendant of its own
- K162418: Pioneer Plus Catheter (2016), 0 descendants of its own

## Recalls of this device
- Jul 22, 2015 · Class II · Z-2718-2015: Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters.
- Apr 30, 2010 · Not classified · Z-0864-2011: Needles may fail to retract and thus cause injury.

## 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 ecclusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus Catheter is not indicated for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K081804
Methodology: https://510kreport.com/methodology