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FDA 510(k)

LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application

K-Number: K230553 · 2023-04-26

ApplicantMedtronic, Inc.
Decision Date2023-04-26
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2023-04-26 under approval number K230553. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application?

LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application is a medical device that received FDA 510(k) clearance on 2023-04-26. It is manufactured by Medtronic, Inc.. The 510(k) number is K230553.

When was LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application approved by the FDA?

LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application received FDA 510(k) clearance on 2023-04-26, under approval number K230553.

What company makes LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application?

LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application is manufactured by Medtronic, Inc..

What is the FDA product code for LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application?

The FDA product code for LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application is MXD.

Related Clinical Trials

NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT07379294 Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery NOT_YET_RECRUITING NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED NCT06172699 Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study COMPLETED NCT05687292 Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children RECRUITING

Related PubMed Literature

PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

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Related Devices (Code: MXD)

K160809Reveal LINQMedtronic, Inc. K160689Reveal LINQMedtronic, Inc. K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc. K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. K162855Reveal LINQMedtronic, 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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