7F HYDROLYSER THROMBECTOMY CATHETER— 510(k) K983534

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K983534 for 7F HYDROLYSER THROMBECTOMY CATHETER, Substantially Equivalent on 1999-02-26. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 1998-10-09
Decision date: 1999-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, US

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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.