# K053372: Lbi Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Lumen Biomedical, Inc.
- Decided: Jun 30, 2006 after 207 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: 4 generations back to K010579 (2001). 11 ancestors in all.
10 later devices descend from it; 1 cites 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)
- K032763: Vascular Solutions Pronto Extraction Catheter, Vascular Solutions, Inc. (2003) Summary page 5.
- K042937: Modification to Vascular Solutions Pronto Extraction Catheter, Vascular Solutions, Inc. (2005) Summary page 5.
- K051193: Vascular Solutions Pronto Short Extraction Catheter, Vascular Solutions, Inc. (2005)
- K052232: Vascular Solutions Pronto V3 Extraction Catheter, Vascular Solutions, Inc. (2005) Summary page 5.
- K040869: Export Catheter, Medtronic Vascular (2004) Summary page 5.
- K050139: Modification to: Export Catheter, Medtronic Vascular (2005) Summary page 5.

## Most influential descendants
- K071529: Xtract Catheter System (2007), 9 descendants of its own
- 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

## Indications for use
The LBI 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/K053372
Methodology: https://510kreport.com/methodology