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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Steerable
510(k) Number K884337
Device Name MICRO-GUIDE SYSTEM
Applicant
Catheter Research C/O Burditt, Bowles & Radzius
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Applicant Contact R RADZIUS
Correspondent
Catheter Research C/O Burditt, Bowles & Radzius
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Correspondent Contact R RADZIUS
Regulation Number870.1280
Classification Product Code
DRA  
Date Received10/14/1988
Decision Date 01/05/1989
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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