Lbi Embolectomy System

Q: What is the product code of K080901?

The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.

FDA 510(k) K080901 · Lumen Biomedical, Inc.

Unknown

510(k) numberK080901

Submission

Device name: Lbi Embolectomy System
Applicant: Lumen Biomedical, Inc.
Plymouth, MN, US
Received: March 31, 2008
Decision date: October 2, 2008
Decision: Unknown (SESU)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QEW – Peripheral Mechanical Thrombectomy With Aspiration
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.5150
Specialty: Cardiovascular

To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.

Other 510(k)s with product code QEW

510(k)	Device	Applicant	Decision
K261800	Helo Max Thrombectomy System (HEL2090)QEW · Traditional	Endovascular Engineering	09/03/2026SE
K262538	Artix MT;Artix Thin-Walled SheathQEW · Special	Inari Medical, Inc.	08/21/2026SE
K261523	Vertex Thrombectomy SystemQEW · Traditional	Jupiter Endovascular	08/04/2026SE
K260599	INDIGO® Aspiration System INDIGO LinkQEW · Traditional	Penumbra, Inc.	04/24/2026SE
K260028	CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece…QEW · Special	Argon Medical Devices, Inc.	02/05/2026SE
K251949	INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW · Traditional	Penumbra, Inc.	02/05/2026SE
K253730	RoVo Mechanical Thrombectomy SystemQEW · Special	Verge Medical, Inc.	01/21/2026SE
K251207	Sangria Thrombectomy SystemQEW · Traditional	Avantec Vascular Corporation	01/07/2026SE
K252956	Helo Thrombectomy SystemQEW · Traditional	Endovascular Engineering, Inc.	12/18/2025SE
K251070	Akura Thrombectomy SystemQEW · Traditional	Akura Medical	11/25/2025SE

More from Akura Medical

510(k)	Device	Decision
K111987	Fibernet Embolic Protection DeviceNTE · Special	08/17/2011SE
K082348	Fibernet Embolic Protection SystemNTE · Traditional	11/18/2008SE
K071529	Xtract Catheter SystemQEZ · Special	08/10/2007SE
K053372	Lbi Catheter SystemQEZ · Traditional	06/30/2006SE

Questions and answers

When was Lbi Embolectomy System cleared by the FDA?

Lbi Embolectomy System (K080901) received a 510(k) decision of Unknown on October 2, 2008, 185 days after the submission was received.

What is the product code of K080901?

The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.