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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 K021421
Device Name PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
Applicant
Tz Medical, Inc.
7272 SW Durham Rd., #800
Portland,  OR  97224
Applicant Contact MADALYN DUNCAN
Correspondent
Tz Medical, Inc.
7272 SW Durham Rd., #800
Portland,  OR  97224
Correspondent Contact MADALYN DUNCAN
Regulation Number870.1220
Classification Product Code
DRF  
Date Received05/03/2002
Decision Date 04/18/2003
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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