510(k) K143604— Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters

Substantially Equivalent

Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S

Clearance details

Applicant: Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2014-12-18
Decision date: 2015-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Catalca, TR

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.