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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, Lead (Dedicated Instruments)
510(k) Number K014195
Device Name KAYAK HYDROPHILIC GUIDE WIRES
Applicant
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact MARK MURPHY
Correspondent
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact MARK MURPHY
Regulation Number862.3550
Classification Product Code
DOX  
Date Received12/21/2001
Decision Date 03/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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