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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K874542
Device Name TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES
Applicant
Toray Industries (America), Inc.
280 Park Ave.
New York,  NY  10017
Applicant Contact KOHKI UENO
Correspondent
Toray Industries (America), Inc.
280 Park Ave.
New York,  NY  10017
Correspondent Contact KOHKI UENO
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/03/1987
Decision Date 03/07/1988
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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