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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 K945379
Device Name PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
Applicant
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472
Applicant Contact MARY P LEGRAW
Correspondent
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472
Correspondent Contact MARY P LEGRAW
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/02/1994
Decision Date 06/05/1995
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
Recalls CDRH Recalls
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