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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K932388
Device Name HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER
Applicant
Heart Rhythm Technologies, Inc.
26531 Ynez Rd.
Temecula,  CA  92591
Applicant Contact MIRAIM TAIMISTO
Correspondent
Heart Rhythm Technologies, Inc.
26531 Ynez Rd.
Temecula,  CA  92591
Correspondent Contact MIRAIM TAIMISTO
Regulation Number870.1220
Classification Product Code
DRF  
Date Received05/17/1993
Decision Date 05/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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