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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology
510(k) Number K892648
Device Name MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177
Applicant
Boston Scientific Corp
480 Pleasant St.
P.O. Box 7407
Watertown,  MA  02272
Applicant Contact ALBERT SEPRINSKI
Correspondent
Boston Scientific Corp
480 Pleasant St.
P.O. Box 7407
Watertown,  MA  02272
Correspondent Contact ALBERT SEPRINSKI
Regulation Number876.1500
Classification Product Code
OCY  
Date Received04/12/1989
Decision Date 05/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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