# K071529: Xtract Catheter System

- Pathway: 510(k) (Special)
- Applicant: Lumen Biomedical, Inc.
- Decided: Aug 10, 2007 after 66 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: 5 generations back to K010579 (2001). 12 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053372: Lbi Catheter System, Lumen Biomedical, Inc. (2006) Summary page 5.

## Most influential descendants
- K080901: Lbi Embolectomy System (2008), 6 descendants of its own
- K113757: Aspire Max Aspiration Catheter (2012), 5 descendants of its own
- K220780: ROVO Mechanical Thrombectomy Device (2023), 1 descendant of its own
- K200871: Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator (2020), 1 descendant of its own
- K082348: Fibernet Embolic Protection System (2008), 1 descendant of its own

## Recalls of this device
- Nov 3, 2010 · Not classified · Z-0445-2011: Potential for product failure. Packaging/Storage issue results in compromised integrity and potential product failure during use, leading to potential patient injury.

## Indications for use
The Xtract® Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Source page: https://510kreport.com/device/K071529
Methodology: https://510kreport.com/methodology