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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K150303
Device Name XXL Vascular Balloon Dilatation Catheter
Applicant
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact Melanie Raska
Correspondent
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact Melanie Raska
Regulation Number870.1250
Classification Product Code
LIT  
Date Received02/06/2015
Decision Date 06/15/2015
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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