CORROSION PROOF SNAP ECG CONNECT WIRES— 510(k) K802236

Substantially Equivalent

Custom Cardio Components

FDA 510(k) clearance K802236 for CORROSION PROOF SNAP ECG CONNECT WIRES, Substantially Equivalent on 1980-10-03. Applicant: Custom Cardio Components.

Clearance details

Applicant: Custom Cardio Components
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 1980-09-15
Decision date: 1980-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.