XTD Thrombectomy Catheter, XX CM

Q: What is the product code of K021641?

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) K021641 · Xtrak Medical, Inc.

Substantially Equivalent

510(k) numberK021641

Submission

Device name: XTD Thrombectomy Catheter, XX CM
Applicant: Xtrak Medical, Inc.
Hopkonton, MA, US
Received: May 20, 2002
Decision date: July 26, 2002
Decision: Substantially Equivalent (SESE)
Type: Special 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
K032660	Xtrak Support CatheterDQY · Traditional	10/29/2003SE
K013473	XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model #…MCW · Traditional	03/06/2002SE

Questions and answers

When was XTD Thrombectomy Catheter, XX CM cleared by the FDA?

XTD Thrombectomy Catheter, XX CM (K021641) received a 510(k) decision of Substantially Equivalent on July 26, 2002, 67 days after the submission was received.

What is the product code of K021641?

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