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FDA 510(k)

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

K-Number: K163316 · 2017-06-22

ApplicantCarefusion 303, Inc.
Decision Date2017-06-22
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is a medical device manufactured by Carefusion 303, Inc.. It received FDA 510(k) clearance on 2017-06-22 under approval number K163316. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System?

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is a medical device that received FDA 510(k) clearance on 2017-06-22. It is manufactured by Carefusion 303, Inc.. The 510(k) number is K163316.

When was Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System approved by the FDA?

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System received FDA 510(k) clearance on 2017-06-22, under approval number K163316.

What company makes Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System?

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is manufactured by Carefusion 303, Inc..

What is the FDA product code for Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System?

The FDA product code for Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is DSA.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Carefusion 303, Inc.

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Related Devices (Code: DSA)

K153188Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd. K152947Disposable Temporary Pacing CableTiger Medical Products K172591Fixed Patient Leads ECG Cable (Model 3153)Boston Scientific Corporation K162768ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cablesIntegral Process Sas K170536ECG Disposable Lead WireAPK Technology Co., Ltd. K162432Multi-Link X2 ECG Cable and Lead Wire SystemCarefusion 2200, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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