QEW

Peripheral Mechanical Thrombectomy With Aspiration

Product code
QEW
Device name
Peripheral Mechanical Thrombectomy With Aspiration
Device class
Class 2
21 CFR
21 CFR 870.5150
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
37
Summaries archived here
35 (direct download)
510(k) clearances (all years, FDA)
143 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (37)

Last three years. Most recent: 2026-08-21.

NumberDecision dateApplicantDevice nameSummary
K2625382026-08-21Inari Medical, Inc.Artix™ MT;Artix™ Thin-Walled SheathFDA
K2615232026-08-04Jupiter EndovascularVertex™ Thrombectomy SystemPDF
K2605992026-04-24Penumbra, Inc.INDIGO® Aspiration System – INDIGO LinkPDF
K2519492026-02-05Penumbra, Inc.INDIGO® Aspiration System - Lightning Flash AspiratiPDF
K2600282026-02-05Argon Medical Devices, Inc.CLEANER™ Vac Thrombectomy System, CLEANER™ Vac AspirPDF
K2537302026-01-21Verge Medical, Inc.RoVo Mechanical Thrombectomy SystemPDF
K2512072026-01-07Avantec Vascular CorporationSangria™ Thrombectomy SystemPDF
K2529562025-12-18Endovascular Engineering, Inc.Helo Thrombectomy SystemPDF
K2510702025-11-25Akura MedicalAkura Thrombectomy SystemPDF
K2533232025-10-29Inari MedicalProtrieve SheathPDF
K2511852025-10-22InterveneRecana Thrombectomy Catheter System (FG014. FG015, FPDF
K2526122025-10-16Penumbra, Inc.INDIGO® Aspiration System – Lightning Flash AspiratiPDF
K2520572025-08-28Imperative Care, Inc.Symphony™ Thrombectomy System and Symphony™ 16F 82cmPDF
K2511892025-06-13Inquis MedicalAventus Thrombectomy SystemPDF
K2514852025-06-13Contego Medical, Inc.Excipio LV Prime Thrombectomy DevicePDF
K2507872025-06-11Medtronic, IrelandLiberant Thrombectomy SystemPDF
K2507752025-05-14Imperative Care, Inc.Symphony™ Thrombectomy System; Symphony™ 16F 82cm ThPDF
K2504212025-05-12Inari Medical, Inc.InThrill™ Thrombectomy SystemPDF
K2506682025-03-25Inquis MedicalAventus Thrombectomy System (IM-2100)PDF
K2500882025-03-13Inari Medical, Inc.FlowTriever2 CatheterPDF
K2502022025-02-26Inquis MedicalAventus Thrombectomy SystemPDF
K2418942024-10-15Inari Medical, Inc.Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathPDF
K2425572024-09-27Inari Medical, Inc.ClotTriever XL Catheter (41-102)PDF
K2420752024-09-25Penumbra, Inc.Indigo® Aspiration System – Lightning Bolt AspiratioPDF
K2413622024-09-11Surmodics,Inc.Pounce XL Thrombectomy System (PTS-1011-7F135)PDF
K2423192024-09-03Penumbra, Inc.Indigo® Aspiration System – Aspiration Catheter 6XPDF
K2339172024-07-18IchorICHOR 7F Embolectomy System (ICH-7F)PDF
K2413992024-06-10Penumbra, Inc.Indigo® Lightning Flash Aspiration System – Select +PDF
K2412072024-05-29Devoro Medical, Inc.SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01),PDF
K2340732024-04-19Expanse Medical, Inc.ICE Aspiration SystemPDF
K2339092024-03-28Argon Medical Devices, Inc.Cleaner™ Plus 18F Thrombectomy System - Cleaner™ PluPDF
K2401172024-03-15Inquis MedicalAventus Thrombectomy System (IM-2001/IM-0002)FDA
K2340342024-02-09Inari Medical, Inc.VenaCore Thrombectomy Catheter (46-101)PDF
K2400302024-02-02Penumbra, Inc.Indigo® Aspiration System - Lightning® FlashPDF
K2326792024-01-19Argon Medical Devices, Inc.Cleaner™ Pro Thrombectomy System; Cleaner™ Pro AspirPDF
K2338152023-12-18Inari Medical, Inc.ClotTriever SheathPDF
K2327302023-11-01Inquis MedicalAventus Thrombectomy SystemPDF

35 summaries are archived here for direct download.

Official FDA classification page: QEW
Classification and pathway per current FDA publications. Data from openFDA (CC0).