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FDA 510(k)

NeVa PV Thrombectomy Device

K-Number: K201085 · 2021-01-15

ApplicantVesalio
Decision Date2021-01-15
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NeVa PV Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is Vesalio. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K201085. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeVa PV Thrombectomy Device?

NeVa PV Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Vesalio. The 510(k) number is K201085.

When did NeVa PV Thrombectomy Device receive FDA 510(k) clearance?

NeVa PV Thrombectomy Device received FDA 510(k) clearance on 2021-01-15, under 510(k) number K201085.

Who is the listed applicant for NeVa PV Thrombectomy Device?

The FDA 510(k) record lists Vesalio as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeVa PV Thrombectomy Device?

The FDA product code for NeVa PV Thrombectomy Device is QEW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04969471NATURE (EnVast as an Adjunct PPCI in Subjects Presenting With STEMI)ACTIVE_NOT_RECRUITINGNCT06893588Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEntsRECRUITING

Other records listing Vesalio as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254211pVasc Net Mechanical Thrombectomy DeviceK251097V-DAC CatheterK253407NeVa PV Thrombectomy DeviceK251006NeVasc Aspiration SystemK251312Vesalio Peripheral System

Related Devices (Code: QEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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