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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Intravascular, Cardiovascular
510(k) Number K963016
Device Name SIMON NITINOL FILTER SYSTEM
Applicant
Nitinol Medical Technologies, Inc.
263 Summer St., 7th Floor
Boston,  MA  02210
Applicant Contact SHERRIE COVAL-GOLDSMITH
Correspondent
Nitinol Medical Technologies, Inc.
263 Summer St., 7th Floor
Boston,  MA  02210
Correspondent Contact SHERRIE COVAL-GOLDSMITH
Regulation Number870.3375
Classification Product Code
DTK  
Date Received08/02/1996
Decision Date 11/18/1996
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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