MEGA ANGIOGRAM KIT— 510(k) K913397

Unknown

Mega Medical, Inc.

FDA 510(k) clearance K913397 for MEGA ANGIOGRAM KIT, Unknown on 1991-10-31. Applicant: Mega Medical, Inc..

Clearance details

Applicant: Mega Medical, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1991-07-30
Decision date: 1991-10-31
Decision: Unknown
Clearance type: Traditional
Location: Tampa, FL, 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.