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FDA 510(k)

CAPERE Thrombectomy System

K-Number: K201216 · 2020-07-08

ApplicantVascular Medcure, Inc.
Decision Date2020-07-08
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPERE Thrombectomy System is a medical device manufactured by Vascular Medcure, Inc.. It received FDA 510(k) clearance on 2020-07-08 under approval number K201216. 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 CAPERE Thrombectomy System?

CAPERE Thrombectomy System is a medical device that received FDA 510(k) clearance on 2020-07-08. It is manufactured by Vascular Medcure, Inc.. The 510(k) number is K201216.

When was CAPERE Thrombectomy System approved by the FDA?

CAPERE Thrombectomy System received FDA 510(k) clearance on 2020-07-08, under approval number K201216.

What company makes CAPERE Thrombectomy System?

CAPERE Thrombectomy System is manufactured by Vascular Medcure, Inc..

What is the FDA product code for CAPERE Thrombectomy System?

The FDA product code for CAPERE Thrombectomy System is QEW.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING NCT07335341 Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System RECRUITING NCT07135895 The ArtixASCEND Study RECRUITING

Other Devices by Vascular Medcure, Inc.

K192935CAPERE Thrombectomy System K183179CAPERE Thrombectomy System K203476CAPERE Thrombectomy System K200314Capere Thrombectomy System

Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari Medical, Inc.

Official Source

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

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