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510(k) K201085

Device
NeVa PV Thrombectomy Device
Applicant
Vesalio
510(k) number
K201085
Product code
QEW  
Decision
Substantially Equivalent (SESE)
Decision date
2021-01-15
Date received
2020-04-23
Regulation
870.5150
Classification name
Peripheral Mechanical Thrombectomy With Aspiration
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gustavo Prado
Address
3200 W. End Ave., Suite 500 Nashville TN US 37203 37203

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QEW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.2026-04-24
K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.2026-02-05
K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.2026-02-05
K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.2026-01-21
K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation2026-01-07
K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.2025-12-18
K251070Akura Thrombectomy SystemAkura Medical2025-11-25
K253323Protrieve SheathInari Medical2025-10-29
K251185Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)Intervene2025-10-22
K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.2025-10-16
K252057Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.2025-08-28
K251485Excipio LV Prime Thrombectomy DeviceContego Medical, Inc.2025-06-13
K251189Aventus Thrombectomy SystemInquis Medical2025-06-13
K250787Liberant Thrombectomy SystemMedtronic, Ireland2025-06-11
K250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.2025-05-14

Legacy Summary#

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FDA Review#

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