FDA 510(k)

Assert-IQ Insertable Cardiac Monitor

K-Number: K230286 · 2023-05-17

Decision Date2023-05-17

Product CodeMXC

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Assert-IQ Insertable Cardiac Monitor is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2023-05-17 under approval number K230286. The device is classified under product code MXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Assert-IQ Insertable Cardiac Monitor?

Assert-IQ Insertable Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2023-05-17. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K230286.

When was Assert-IQ Insertable Cardiac Monitor approved by the FDA?

Assert-IQ Insertable Cardiac Monitor received FDA 510(k) clearance on 2023-05-17, under approval number K230286.

What company makes Assert-IQ Insertable Cardiac Monitor?

Assert-IQ Insertable Cardiac Monitor is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Assert-IQ Insertable Cardiac Monitor?

The FDA product code for Assert-IQ Insertable Cardiac Monitor is MXC.

Related Clinical Trials

NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT06172699 Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study COMPLETED NCT07405333 Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery. RECRUITING NCT06589700 B2AD-Risk AFDAS Evolution of Burden of AF RECRUITING NCT03505801 Confirm Rx Insertable Cardiac Monitor SMART Registry COMPLETED

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Related Devices (Code: MXC)

K173232myMerlin(TM) Mobile Application Model APP1001St Jude Medical K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. K192593Confirm Rx Insertable Cardiac MonitorAbbott K190295Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) K182981Confirm Rx Insertable Cardiac MonitorAbbott K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)

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.