TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET— 510(k) K102430

Substantially Equivalent

Tyco Electronics Corporation

FDA 510(k) clearance K102430 for TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET, Substantially Equivalent on 2010-09-10. Applicant: Tyco Electronics Corporation.

Clearance details

Applicant: Tyco Electronics Corporation
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2010-08-26
Decision date: 2010-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilsonville, OR, 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.