PATIENT CABLE— 510(k) K080112

Substantially Equivalent

Med-Dyne

FDA 510(k) clearance K080112 for PATIENT CABLE, Substantially Equivalent on 2008-06-20. Applicant: Med-Dyne.

Clearance details

Applicant: Med-Dyne
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2008-01-16
Decision date: 2008-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.