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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 K926549
Device Name ENDOCATH ELECTROPHYSIOLOGY CATHETER
Applicant
Endo-Therapeutics, Inc.
1380 Energy Ln.
Suite 110
St. Paul,  MN  55108
Applicant Contact JEFFREY R BUDD
Correspondent
Endo-Therapeutics, Inc.
1380 Energy Ln.
Suite 110
St. Paul,  MN  55108
Correspondent Contact JEFFREY R BUDD
Regulation Number870.1220
Classification Product Code
DRF  
Date Received12/31/1992
Decision Date 12/06/1993
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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