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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 K871047
Device Name RADIOPAQUE SPHERICAL EMBOLI (RSE)
Applicant
Interventional Therapeutics Corp.
664 S. San Marcos Rd.
Santa Barbara,  CA  93111
Applicant Contact JULIE D BELL
Correspondent
Interventional Therapeutics Corp.
664 S. San Marcos Rd.
Santa Barbara,  CA  93111
Correspondent Contact JULIE D BELL
Regulation Number882.5950
Classification Product Code
HCG  
Date Received03/17/1987
Decision Date 05/22/1987
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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