ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608— 510(k) K080806

Substantially Equivalent

Possis Medical, Inc.

FDA 510(k) clearance K080806 for ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608, Substantially Equivalent on 2008-04-04. Applicant: Possis Medical, Inc..

Clearance details

Applicant: Possis Medical, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2008-03-21
Decision date: 2008-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
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.