MEDI-TRACE— 510(k) K811410

Substantially Equivalent

Graphic Controls Corp.

FDA 510(k) clearance K811410 for MEDI-TRACE, Substantially Equivalent on 1981-06-12. Applicant: Graphic Controls Corp..

Clearance details

Applicant: Graphic Controls Corp.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 1981-05-19
Decision date: 1981-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.