MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS— 510(k) K801828

Substantially Equivalent

Graphic Controls Corp.

FDA 510(k) clearance K801828 for MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS, Substantially Equivalent on 1980-08-27. Applicant: Graphic Controls Corp..

Clearance details

Applicant: Graphic Controls Corp.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1980-07-31
Decision date: 1980-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.