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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 K132430
Device Name STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
Applicant
Boston Scientific Corp
One Scimed Place
Maple Grove,  MN  55311 -1566
Applicant Contact CHRISTOPHER DACHEL
Correspondent
Boston Scientific Corp
One Scimed Place
Maple Grove,  MN  55311 -1566
Correspondent Contact CHRISTOPHER DACHEL
Regulation Number870.1250
Classification Product Code
LIT  
Date Received08/05/2013
Decision Date 10/17/2013
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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