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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agents, Embolic, For Treatment Of Uterine Fibroids
510(k) Number K030966
Device Name CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
10 GLENS FALLS TECHNICAL PARK
GLENS FALLS,  NY  12801 -3864
Applicant Contact JODI LYNN GREENIZEN
Correspondent
BOSTON SCIENTIFIC CORP.
10 GLENS FALLS TECHNICAL PARK
GLENS FALLS,  NY  12801 -3864
Correspondent Contact JODI LYNN GREENIZEN
Regulation Number870.3300
Classification Product Code
NAJ  
Date Received03/27/2003
Decision Date 09/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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