OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT— 510(k) K844854

Substantially Equivalent

Vas-Cath of Canada , Ltd.

FDA 510(k) clearance K844854 for OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT, Substantially Equivalent on 1985-05-21. Applicant: Vas-Cath of Canada , Ltd..

Clearance details

Applicant: Vas-Cath of Canada , Ltd.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1984-12-13
Decision date: 1985-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, L5a 3v3, CA

Download summary PDF View on FDA.gov ↗

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.