Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Confirm Rx Insertable Cardiac Monitor

K-Number: K202876 · 2020-12-01

ApplicantAbbott (St. Jude Medical)
Decision Date2020-12-01
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Confirm Rx Insertable Cardiac Monitor is a medical device manufactured by Abbott (St. Jude Medical). It received FDA 510(k) clearance on 2020-12-01 under approval number K202876. 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 Confirm Rx Insertable Cardiac Monitor?

Confirm Rx Insertable Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2020-12-01. It is manufactured by Abbott (St. Jude Medical). The 510(k) number is K202876.

When was Confirm Rx Insertable Cardiac Monitor approved by the FDA?

Confirm Rx Insertable Cardiac Monitor received FDA 510(k) clearance on 2020-12-01, under approval number K202876.

What company makes Confirm Rx Insertable Cardiac Monitor?

Confirm Rx Insertable Cardiac Monitor is manufactured by Abbott (St. Jude Medical).

What is the FDA product code for Confirm Rx Insertable Cardiac Monitor?

The FDA product code for Confirm Rx Insertable Cardiac Monitor is MXC.

Related Clinical Trials

NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT06099015 Cera™ Vascular Plug System Post-Market Clinical Follow-Up RECRUITING NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT06172699 Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study COMPLETED NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT07405333 Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery. RECRUITING

Other Devices by Abbott (St. Jude Medical)

K190295Confirm Rx Insertable Cardiac Monitor K202888Confirm Rx Insertable Cardiac Monitor K200721Agilis HisPro Steerable Catheter With Electrodes K193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) K212206Jot Dx Insertable Cardiac Monitor

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 K202888Confirm 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.

↑