Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator— 510(k) K200871
Substantially EquivalentControl 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.
Clearance details
- Applicant
- Control Medical Technology
- Product code
- Code QEZ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
Adverse events under product code QEZ
product code QEZ- Death
- 24
- Total
- 24
Source: openFDA MAUDE database, through . 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.