MegaVac Mechanical Thrombectomy System— 510(k) K171493

Name: FDA 510(k) clearance K171493
Creator: U.S. Food and Drug Administration
Published: 2017-08-10

Substantially Equivalent

Capture Vascular, Inc.

FDA 510(k) clearance K171493 for MegaVac Mechanical Thrombectomy System, Substantially Equivalent on 2017-08-10. Applicant: Capture Vascular, Inc.. Device class: 2.

Clearance details

Applicant: Capture Vascular, Inc.
Product code: Code QEX
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2017-05-22
Decision date: 2017-08-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain Village, CO, US

Download summary PDF View on FDA.gov ↗

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