Home / 510(k) Clearances / K101968

510(k) K101968

SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A by St Jude Medical — Product Code MXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2010
Date Received
July 12, 2010
Clearance Type
Special
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

  • K181382 — GuardianTM Burr Hole Cover System (July 20, 2018)
  • K172396 — EnSite Velocity Cardiac Mapping System v5.2 (April 23, 2018)
  • K173232 — myMerlin(TM) Mobile Application Model APP1001 (November 2, 2017)
  • K160218 — AutoMark Module (December 13, 2016)
  • K160335 — Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL (December 13, 2016)
  • K162643 — MediGuide Technology System (December 13, 2016)
  • K160210 — EnSite Precision Cardiac Mapping System v2.0 (December 13, 2016)
  • K161873 — Pacel Flow Directed Pacing Catheter (November 22, 2016)
  • K160187 — Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 (October 21, 2016)
  • K160186 — EnSite Velocity Surface Electrode Kit (October 7, 2016)

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)
  • K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) System (September 29, 2017)