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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K023337
Device Name CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
Applicant
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Applicant Contact PAIGE SWEENEY
Correspondent
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Correspondent Contact PAIGE SWEENEY
Regulation Number874.4680
Classification Product Code
KTI  
Date Received10/07/2002
Decision Date 11/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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