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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K944354
Device Name CONTOUR EMBOLI
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 Number882.5950
Classification Product Code
HCG  
Date Received08/30/1994
Decision Date 12/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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