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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 K942379
Device Name DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
Applicant
Daig Corp.
14901 Deveau Pl.
Minnetonka,  MN  55345
Applicant Contact JOHN J FLEISCHHACKER
Correspondent
Daig Corp.
14901 Deveau Pl.
Minnetonka,  MN  55345
Correspondent Contact JOHN J FLEISCHHACKER
Regulation Number870.1220
Classification Product Code
DRF  
Date Received05/09/1994
Decision Date 12/27/1994
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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