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FDA 510(k)

Confirm Rx Insertable Cardiac Monitor

K-Number: K190295 · 2019-04-10

ApplicantAbbott (St. Jude Medical)
Decision Date2019-04-10
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 2019-04-10 under approval number K190295. 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 2019-04-10. It is manufactured by Abbott (St. Jude Medical). The 510(k) number is K190295.

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

Confirm Rx Insertable Cardiac Monitor received FDA 510(k) clearance on 2019-04-10, under approval number K190295.

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.

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Other Devices by Abbott (St. Jude Medical)

K202876Confirm 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 K182981Confirm Rx Insertable Cardiac MonitorAbbott K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) 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.

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