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FDA Product Code

FDA Product Code QEX — Clearance Directory

Device Class
Class II
Assigned Panel
Cardiovascular
21 CFR Citation
870.5150

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K253407 NeVa PV Thrombectomy Device Vesalio, Inc. 2025-11-24 Traditional PDF ↗
K171493 MegaVac Mechanical Thrombectomy System Capture Vascular, Inc. 2017-08-10 Special PDF ↗
K163618 INDIGO Aspiration System Penumbra, Inc. 2017-05-24 Traditional PDF ↗

Product code QEX · Class II · Cardiovascular. Data: openFDA.