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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biliary catheter for stone removal that may also allow for irrigation and contrast injection
510(k) Number K931619
Device Name MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Applicant Contact SHERI D O'BRIEN
Correspondent
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Correspondent Contact SHERI D O'BRIEN
Regulation Number876.5010
Classification Product Code
GCA  
Date Received04/02/1993
Decision Date 08/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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