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FDA 510(k)

Jot Dx Insertable Cardiac Monitor

K-Number: K212206 · 2021-08-13

ApplicantAbbott (St. Jude Medical)
Decision Date2021-08-13
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Jot Dx Insertable Cardiac Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Abbott (St. Jude Medical). It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K212206. 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 Jot Dx Insertable Cardiac Monitor?

Jot Dx Insertable Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Abbott (St. Jude Medical). The 510(k) number is K212206.

When did Jot Dx Insertable Cardiac Monitor receive FDA 510(k) clearance?

Jot Dx Insertable Cardiac Monitor received FDA 510(k) clearance on 2021-08-13, under 510(k) number K212206.

Who is the listed applicant for Jot Dx Insertable Cardiac Monitor?

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

What is the FDA product code for Jot Dx Insertable Cardiac Monitor?

The FDA product code for Jot Dx 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 (St. Jude Medical) 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.

K202876Confirm Rx Insertable Cardiac MonitorK202888Confirm Rx Insertable Cardiac MonitorK200721Agilis HisPro Steerable Catheter With ElectrodesK193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)K190295Confirm Rx Insertable Cardiac Monitor

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 MEDICALK202876Confirm 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)K192593Confirm Rx Insertable Cardiac MonitorAbbottK190295Confirm 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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