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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K102082
Device Name EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
Applicant
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact LAURIE PANNELLA
Correspondent
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact LAURIE PANNELLA
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/26/2010
Decision Date 08/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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