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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, Diagnostic
510(k) Number K950398
Device Name CATHETER, BALLOON TYPE
Applicant
Interventional Therapeutics Corp.
48668 Milmont Dr.
Fremont,  CA  94538
Applicant Contact LYNN K BELL
Correspondent
Interventional Therapeutics Corp.
48668 Milmont Dr.
Fremont,  CA  94538
Correspondent Contact LYNN K BELL
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/01/1995
Decision Date 10/05/1995
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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