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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, Cutting/Scoring
510(k) Number K070951
Device Name 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
Applicant
Boston Scientific
3574 Ruffin Rd.
San Diego,  CA  92123
Applicant Contact BRIAN PARK
Correspondent
Boston Scientific
3574 Ruffin Rd.
San Diego,  CA  92123
Correspondent Contact BRIAN PARK
Regulation Number870.1250
Classification Product Code
PNO  
Date Received04/04/2007
Decision Date 06/04/2007
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
Recalls CDRH Recalls
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