NAMIC ADB ANGIOGRAPHIC DUMP BAG— 510(k) K843726

Substantially Equivalent

North American Instrument Corp.

FDA 510(k) clearance K843726 for NAMIC ADB ANGIOGRAPHIC DUMP BAG, Substantially Equivalent on 1984-10-18. Applicant: North American Instrument Corp..

Clearance details

Applicant: North American Instrument Corp.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1984-09-24
Decision date: 1984-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson Falls, NY, US

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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.