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510(k) K142182

FRIMAP ADAPTER CONNECTOR (MAC) by Topera, Inc. — Product Code MTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2014
Date Received
August 8, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intracardiac Mapping, High-Density Array
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Topera, Inc.

  • K151245 — Rhythm View Workstation (non-streaming, steaming option) (September 15, 2015)
  • K142901 — RhythmView Workstation (December 19, 2014)
  • K133305 — RHYTHM VIEW WORKSTATION (December 16, 2013)
  • K130827 — FIRMAP CATHETER (October 31, 2013)
  • K123295 — RHYTHM VIEW (April 24, 2013)
  • K110878 — RHYTHMVIEW (TM) (September 23, 2011)

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  • K223666 — Ablacath™ Mapping Catheter (March 17, 2023)
  • K230253 — OPTRELL™ Mapping Catheter with TRUEref™ Technology (March 2, 2023)
  • K210766 — AcQMap 3D Imaging and Mapping Catheter, Model 900009 (June 21, 2022)
  • K211438 — OPTRELL Mapping Catheter with TRUEref Technology (March 18, 2022)
  • K201806 — Reprocessed PentaRay Nav eco High-Density Mapping Catheter (June 23, 2021)
  • K201341 — AcQMap 3D Imaging and Mapping Catheter (September 15, 2020)