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FDA 510(k)

Confirm Rx Insertable Cardiac Monitor (ICM) System

K-Number: K163407 · 2017-09-29

ApplicantSt. Jude Medical, Inc.
Decision Date2017-09-29
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Confirm Rx Insertable Cardiac Monitor (ICM) System is a medical device manufactured by St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2017-09-29 under approval number K163407. 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 (ICM) System?

Confirm Rx Insertable Cardiac Monitor (ICM) System is a medical device that received FDA 510(k) clearance on 2017-09-29. It is manufactured by St. Jude Medical, Inc.. The 510(k) number is K163407.

When was Confirm Rx Insertable Cardiac Monitor (ICM) System approved by the FDA?

Confirm Rx Insertable Cardiac Monitor (ICM) System received FDA 510(k) clearance on 2017-09-29, under approval number K163407.

What company makes Confirm Rx Insertable Cardiac Monitor (ICM) System?

Confirm Rx Insertable Cardiac Monitor (ICM) System is manufactured by St. Jude Medical, Inc..

What is the FDA product code for Confirm Rx Insertable Cardiac Monitor (ICM) System?

The FDA product code for Confirm Rx Insertable Cardiac Monitor (ICM) System is MXC.

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Related PubMed Literature

PMID: 40415770 Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory. REC, interventional cardiology (2024)

Other Devices by St. Jude Medical, Inc.

K161171PressureWire X Guidewire K161102Nanostim Introducer Kit K160716The Nanostim Introducer Kit K172393Advisor HD Grid Mapping Catheter, Sensor Enabled PMA P880006Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Related Devices (Code: MXC)

K173232myMerlin(TM) Mobile Application Model APP1001St Jude Medical 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) 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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