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510(k) K130827

FIRMAP CATHETER by Topera, Inc. — Product Code MTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2013
Date Received
March 26, 2013
Clearance Type
Traditional
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.

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  • K133305 — RHYTHM VIEW WORKSTATION (December 16, 2013)
  • K123295 — RHYTHM VIEW (April 24, 2013)
  • K110878 — RHYTHMVIEW (TM) (September 23, 2011)

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