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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K843118
Device Name CANNULA INTRODUCER
Applicant
Cardiovascular Research, Inc.
5800 49th St. N. Suite S207
St Petersburg,  FL  33709
Applicant Contact DEAN M RAZI
Correspondent
Cardiovascular Research, Inc.
5800 49th St. N. Suite S207
St Petersburg,  FL  33709
Correspondent Contact DEAN M RAZI
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/08/1984
Decision Date 11/13/1984
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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