510(k) K251488

Device
FLOWRUNNER Aspiration System
Applicant
Expanse Medical, Inc.
510(k) number
K251488
Product code
QEZ
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-14
Date received
2025-05-14
Regulation
870.5150
Classification name
Aspiration Thrombectomy Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Shiva Ardakani
Address
7060 Koll Canter Pkwy. Suite 300 Pleasanton CA US 94566 94566

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code QEZ

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K253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc.2026-04-23
K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.2026-03-20
K253925Aventus Thrombectomy SystemInquis Medical2026-01-15
K252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc.2025-11-24
K251312Vesalio Peripheral SystemVesalio, Inc.2025-10-24
K243549JETi Hydrodynamic Thrombectomy SystemABBOTT MEDICAL2025-04-04
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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