# K072155: Pioneer Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Oct 5, 2007 after 63 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: 3 generations back to K001577 (2001). 3 ancestors in all.
3 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)
- K013363: Crosspoint Transaccess Catheter, Trans Vascular Incorporated (2002) Summary page 1.
- K031920: Crosspoint Transaccess Catheter, Model TA-XP-001, Trans Vascular Incorporated (2003) Summary page 1.

## Most influential descendants
- K081804: Pioneer Plus Catheter (2008), 2 descendants of its own
- K101777: Pioneer Plus Catheter, Model Plus 120 (2010), 1 descendant of its own
- K162418: Pioneer Plus Catheter (2016), 0 descendants of its own

## Indications for use
The Pioneer catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer 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. PTCA, stent, etc.). The Pioneer catheter is not indicated for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K072155
Methodology: https://510kreport.com/methodology