Multi-Link X2 ECG Cable and Lead Wire System— 510(k) K162432

Substantially Equivalent

Carefusion 2200, Inc.

FDA 510(k) clearance K162432 for Multi-Link X2 ECG Cable and Lead Wire System, Substantially Equivalent on 2017-01-18. Applicant: Carefusion 2200, Inc..

Clearance details

Applicant: Carefusion 2200, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2016-08-31
Decision date: 2017-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, 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.