ASPIRE MAX ASPIRATION CATHETER— 510(k) K113757

Substantially Equivalent

Control Medical Technology, LLC

FDA 510(k) clearance K113757 for ASPIRE MAX ASPIRATION CATHETER, Substantially Equivalent on 2012-02-22. Applicant: Control Medical Technology, LLC.

Clearance details

Applicant: Control Medical Technology, LLC
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2011-12-21
Decision date: 2012-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park City, UT, US

Download summary PDF View on FDA.gov ↗

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.