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Capere Thrombectomy System

by Kp Medcure, Inc. 510(k)

Active United States

510(k) K180722

Overview

The Capere Thrombectomy System is a peripheral mechanical thrombectomy device with aspiration, used for the removal of soft emboli and thrombi from blood vessels. It is designed for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

The device is supplied as a single-use system and is regulated under FDA 510K clearance, with a product code of QEW and regulation number 870.5150. It is intended for use in the removal of soft emboli and thrombi from peripheral blood vessels, and features a mechanical retrieval method with aspiration capability.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180722 Date11 Jun 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
QEW
Device Class
Class II
Regulation
21 CFR Part 870.5150
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Capere Thrombectomy System used for?

    The Capere Thrombectomy System is used for the removal of soft emboli and thrombi from peripheral blood vessels, utilizing a mechanical retrieval method with aspiration capability.

  • Is the Capere Thrombectomy System reusable?

    No, the Capere Thrombectomy System is supplied as a single-use system.

  • What regulatory clearance does the Capere Thrombectomy System have?

    The Capere Thrombectomy System is regulated under FDA 510K clearance with a product code of QEW and regulation number 870.5150.