# K112571: XL Extraction Catheter

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Oct 6, 2011 after 30 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970657 (1997). 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)
- K070403: Pronto .035 Extraction Catheter, Vascular Solutions, Inc. (2007) Summary page 5.

## Most influential descendants
- K173266: Octane aspiration system (2017), 1 descendant of its own
- K182232: Octane Mechanical Thrombectomy System (2018), 0 descendants of its own

## Indications for use
The XL extraction catheter is indicated for: * the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system * the removal/aspiration of embolic material (thrombus/debris) from vessels of the deep venous system * to infuse/deliver diagnostic or therapeutic agents

Source page: https://510kreport.com/device/K112571
Methodology: https://510kreport.com/methodology