# K080901: Lbi Embolectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Lumen Biomedical, Inc.
- Decided: Oct 2, 2008 after 185 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- 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: 7 generations back to K904788 (1990). 69 ancestors in all.
6 later devices descend from it; 1 cites it directly.
3 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071529: Xtract Catheter System, Lumen Biomedical, Inc. (2007) Summary page 6.
- K892410: Fogarty (R) Thru-Lumen Embolectomy Catheter, Baxter Healthcare Corp (1989) Summary page 6.
- K002627: Atrium Medical Corporation Clearway Ptfe Balloon Catheter, Atrium Medical Corp. (2001) Summary page 6.
- K062275: Rinspiration Catheter System, Models 50135, 550135, P7065, P70135, Kerberos Proximal Solutions, Inc. (2006) Summary page 6.
- K050130: Kerberos Proximal Solutions Rispiration System, Kerberos Proximal Solutions, Inc. (2005)
- K040010: Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) Systems, Genesis Medical Interventional, Inc. (2004) Summary page 6.
- K991093: MSD Embolectomy Basket, Metamorphic Surgical Devices, LLC (2000) Summary page 6.
- K990639: Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating., Guidant Corp. (1999) Summary page 6.
- K994358: Atw Marker Wire Steerable Guidewire, Cordis Corp. (2000) Summary page 6.

## Most influential descendants
- 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
- K253730: RoVo Mechanical Thrombectomy System (2026), 0 descendants of its own
- K250013: VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) (2025), 0 descendants of its own

## Indications for use
The LBI Embolectomy System is indicated for use in removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

Source page: https://510kreport.com/device/K080901
Methodology: https://510kreport.com/methodology