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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K860497
Device Name CAROTID BALLOON SHUNT
Applicant
Imodex, Inc.
29001 Harper Ave. Suite 5
St. Clair Shores,  MI  48081
Applicant Contact SHELDON DAVIS
Correspondent
Imodex, Inc.
29001 Harper Ave. Suite 5
St. Clair Shores,  MI  48081
Correspondent Contact SHELDON DAVIS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/10/1986
Decision Date 05/28/1986
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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