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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 Occluding, Temporary
510(k) Number K960715
Device Name PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F
Applicant
Ideas For Medicine, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Applicant Contact ELIZABETH M PAUL
Correspondent
Ideas For Medicine, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Correspondent Contact ELIZABETH M PAUL
Regulation Number870.4450
Classification Product Code
MJN  
Date Received02/21/1996
Decision Date 09/09/1996
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
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