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FDA 510(k)

Confirm Rx Insertable Cardiac Monitor

K-Number: K192593 · 2019-10-18

ApplicantAbbott
Decision Date2019-10-18
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Confirm Rx Insertable Cardiac Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K192593. 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 2019-10-18. The listed applicant is Abbott. The 510(k) number is K192593.

When did Confirm Rx Insertable Cardiac Monitor receive FDA 510(k) clearance?

Confirm Rx Insertable Cardiac Monitor received FDA 510(k) clearance on 2019-10-18, under 510(k) number K192593.

Who is the listed applicant for Confirm Rx Insertable Cardiac Monitor?

The FDA 510(k) record lists Abbott as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03505801Confirm Rx Insertable Cardiac Monitor SMART RegistryCOMPLETEDNCT04790344LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.ACTIVE_NOT_RECRUITINGNCT06172699Assert-IQ Implantable Cardiac Monitor (ICM) Post Market StudyCOMPLETEDNCT06832579SmartWatch-driven AF Detection in Stroke PatientsACTIVE_NOT_RECRUITING

Other records listing Abbott as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterPMA P170038Ventricular (assist) bypassK260993Amplatzer TorqVue Delivery SystemK251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)K233655Lingo Glucose SystemK222297CentriMag Pre-connected Pack

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Related Devices (Code: MXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230286Assert-IQ™ Insertable Cardiac MonitorABBOTT MEDICALK212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical)K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)K202888Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)K193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)Abbott (St. Jude Medical)K190295Confirm 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.

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