FDA.report

510(k) K240397

Device
AlphaVac MMA F1885 System (H787253020)
Applicant
AngioDynamics, Inc.
510(k) number
K240397
Product code
QEZ
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-01
Date received
2024-02-09
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
No

Related Records

Applicant Contact

Contact
Kasey Newcomb
Address
603 Queensbury Ave. Queensburgy NY US 12804 12804

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code QEZ

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K253925Aventus Thrombectomy SystemInquis Medical2026-01-15
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
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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