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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K024000
Device Name METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER
Applicant
Angiometrx, Inc.
936 11th Ave. E.
Seattle,  WA  98102
Applicant Contact CARL YOUNGMANN
Correspondent
Angiometrx, Inc.
936 11th Ave. E.
Seattle,  WA  98102
Correspondent Contact CARL YOUNGMANN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/04/2002
Decision Date 06/26/2003
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
Recalls CDRH Recalls
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