510(k) K253925

Device
Aventus Thrombectomy System
Applicant
Inquis Medical
510(k) number
K253925
Product code
QEZ
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-15
Date received
2025-12-08
Regulation
870.5150
Classification name
Aspiration Thrombectomy Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Zachary Woodson
Address
1530 O'Brien Dr. Suite A Menlo Park CA US 94025 94025

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code QEZ

510(k)DeviceApplicantDecision date
K253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc.2026-04-23
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K252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc.2025-11-24
K251312Vesalio Peripheral SystemVesalio, Inc.2025-10-24
K251488FLOWRUNNER Aspiration SystemExpanse Medical, Inc.2025-07-14
K243549JETi Hydrodynamic Thrombectomy SystemABBOTT MEDICAL2025-04-04
K250013VentiV 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)Control Medical Technology, Inc. / Dba Ventiv Scientific2025-03-24
K240397AlphaVac MMA F1885 System (H787253020)AngioDynamics, Inc.2024-04-01
K232458JETi™Hydrodynamic Thrombectomy SystemABBOTT MEDICAL2023-12-19
K213388AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemAngioDynamics, Inc.2022-04-04
K213565JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC2022-02-01
K212199ASAP Aspiration Catheter, ASAPLP Aspiration CatheterMerit Medical Systems, Inc.2021-11-03
K213166Thrombuster II Aspiration CatheterKaneka Medical America, LLC2021-10-26
K211081AlphaVac Multipurpose Mechanical Aspiration (MMA) SystemAngioDynamics, Inc.2021-06-04
K201998JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC2020-11-17