# K061958: Medtronic Export XT Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Sep 5, 2006 after 56 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010579 (2001). 7 ancestors in all.
30 later devices descend from it; 7 cite it directly.
2 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040869: Export Catheter, Medtronic Vascular (2004) Summary page 5.

## Most influential descendants
- K081573: Medtronic Export AP Catheter (2008), 11 descendants of its own
- K072990: Guardwire Temporary Occlusion and Aspiration System- Carotid (2007), 8 descendants of its own
- K120808: Export XT Catheter, Export AP Catheter (2012), 5 descendants of its own
- K113757: Aspire Max Aspiration Catheter (2012), 5 descendants of its own
- K083300: Gore Flow Reversal System (2009), 5 descendants of its own

## Recalls of this device
- Aug 29, 2007 · Not classified · Z-0063-2008: Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.

## Indications for use
The Medtronic Export® XT Catheter is indicated for: Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and To subselectively infuse/deliver diagnostics or therapeutics agents with or without vessel occlusion.

Source page: https://510kreport.com/device/K061958
Methodology: https://510kreport.com/methodology