CORONARY VEIN GRAFT MARKER— 510(k) K882314

Substantially Equivalent

Med-Edge, Inc.

FDA 510(k) clearance K882314 for CORONARY VEIN GRAFT MARKER, Substantially Equivalent on 1988-08-04. Applicant: Med-Edge, Inc..

Clearance details

Applicant: Med-Edge, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1988-06-03
Decision date: 1988-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clemmons, NC, US

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Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.