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510(k) K163407

Confirm Rx Insertable Cardiac Monitor (ICM) System by St. Jude Medical, Inc. — Product Code MXC

K163407 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Inc. for the device "Confirm Rx Insertable Cardiac Monitor (ICM) System". The FDA issued a decision of Substantially Equivalent on September 29, 2017. The device falls under product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.2800. St. Jude Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2017
Date Received
December 5, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by St. Jude Medical, Inc.

  • K172393 — Advisor HD Grid Mapping Catheter, Sensor Enabled (April 23, 2018)
  • K161171 — PressureWire X Guidewire (August 15, 2016)
  • K161102 — Nanostim Introducer Kit (May 19, 2016)
  • K160716 — The Nanostim Introducer Kit (April 14, 2016)
  • K140793 — NANOSTIM INTRODUCER KIT (December 17, 2014)
  • K133481 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (May 28, 2014)
  • K131592 — ENLIGHTN RENAL GUIDE CATHETER (January 31, 2014)
  • K073700 — 6F PROXIS SYSTEM (October 2, 2008)
  • K042734 — SJM RIGID SADDLE RING MODEL RSAR-(SIZE) (December 17, 2004)
  • K022363 — SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) (September 19, 2002)

Other clearances for product code MXC

  • K230286 — Assert-IQ™ Insertable Cardiac Monitor (May 17, 2023)
  • K212206 — Jot Dx Insertable Cardiac Monitor (August 13, 2021)
  • K202876 — Confirm Rx Insertable Cardiac Monitor (December 1, 2020)
  • K202888 — Confirm Rx Insertable Cardiac Monitor (November 23, 2020)
  • K193310 — myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (March 17, 2020)
  • K192593 — Confirm Rx Insertable Cardiac Monitor (October 18, 2019)
  • K190295 — Confirm Rx Insertable Cardiac Monitor (April 10, 2019)
  • K182981 — Confirm Rx Insertable Cardiac Monitor (March 29, 2019)
  • K173232 — myMerlin(TM) Mobile Application Model APP1001 (November 2, 2017)
  • K133481 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (May 28, 2014)

FDA data resources