Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator— 510(k) K200871

Name: FDA 510(k) clearance K200871
Creator: U.S. Food and Drug Administration
Published: 2020-05-04

Substantially Equivalent

Control Medical Technology

FDA 510(k) clearance K200871 for Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator, Substantially Equivalent on 2020-05-04. Applicant: Control Medical Technology. Device class: 2.

Clearance details

Applicant: Control Medical Technology
Product code: Code QEZ
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2020-04-01
Decision date: 2020-05-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.