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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 K850271
Device Name ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR
Applicant
Angiomedics, Inc.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Applicant Contact RICHARD BENNETT
Correspondent
Angiomedics, Inc.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Correspondent Contact RICHARD BENNETT
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/23/1985
Decision Date 04/03/1985
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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