ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER— 510(k) K050794

Substantially Equivalent

Possis Medical, Inc.

FDA 510(k) clearance K050794 for ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER, Substantially Equivalent on 2005-04-28. Applicant: Possis Medical, Inc..

Clearance details

Applicant: Possis Medical, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2005-03-29
Decision date: 2005-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, 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.