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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K053118
Device Name STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX
Applicant
Boston Scientific Corp
Two Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact MAUREEN MARY MONTBRIAND
Correspondent
Boston Scientific Corp
Two Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact MAUREEN MARY MONTBRIAND
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/07/2005
Decision Date 12/16/2005
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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