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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 K061678
Device Name PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25
Applicant
Prorhythm
105 Comac St.
Ronkonkoma,  NY  11779
Applicant Contact JOHN J TALARICO
Correspondent
Prorhythm
105 Comac St.
Ronkonkoma,  NY  11779
Correspondent Contact JOHN J TALARICO
Regulation Number870.1220
Classification Product Code
DRF  
Date Received06/15/2006
Decision Date 01/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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