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FDA 510(k)

Multi-Link X2 ECG Cable and Leadwire System

K-Number: K211294 · 2021-08-16

ApplicantVyaire Medical, Inc.
Decision Date2021-08-16
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Multi-Link X2 ECG Cable and Leadwire System is a medical device manufactured by Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2021-08-16 under approval number K211294. 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 Cable and Leadwire System?

Multi-Link X2 ECG Cable and Leadwire System is a medical device that received FDA 510(k) clearance on 2021-08-16. It is manufactured by Vyaire Medical, Inc.. The 510(k) number is K211294.

When was Multi-Link X2 ECG Cable and Leadwire System approved by the FDA?

Multi-Link X2 ECG Cable and Leadwire System received FDA 510(k) clearance on 2021-08-16, under approval number K211294.

What company makes Multi-Link X2 ECG Cable and Leadwire System?

Multi-Link X2 ECG Cable and Leadwire System is manufactured by Vyaire Medical, Inc..

What is the FDA product code for Multi-Link X2 ECG Cable and Leadwire System?

The FDA product code for Multi-Link X2 ECG Cable and Leadwire System is DSA.

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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)

Other Devices by Vyaire Medical, Inc.

K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART K171678Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable K191273Multi-Link X2 ECG and SpO2 Adapter K190853Vyntus BODY K200510Multi-LinkTM X2 ECG Adapter and Leadwires K201082LTV2 Series Ventilators

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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 K163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. K170536ECG Disposable Lead WireAPK Technology Co., Ltd.

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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