K990805

Substantially Equivalent

MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER

Applicant: Cordis Corp.
Product code: QEZ
Advisory panel: Cardiovascular
Date received: 1999-03-11
Decision date: 1999-03-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami Lakes, FL, US

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.