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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Vascular
510(k) Number K914523
Device Name CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL
Applicant
Catheter Research C/O Burditt, Bowles & Radzius
6131 W. 80th St.
Indianapolis,  IN  46278
Applicant Contact BRIAN GRIGSBY
Correspondent
Catheter Research C/O Burditt, Bowles & Radzius
6131 W. 80th St.
Indianapolis,  IN  46278
Correspondent Contact BRIAN GRIGSBY
Regulation Number870.3250
Classification Product Code
DSS  
Date Received10/10/1991
Decision Date 01/10/1992
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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