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FDA 510(k) Application Details - K032436
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K032436
Device Name
Catheter, Biliary, Diagnostic
Applicant
AVANTEC VASCULAR CORP.
1049 KIEL CT.
SUNNYVALE, CA 94089 US
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Contact
JAMES M SHY
Other 510(k) Applications for this Contact
Regulation Number
876.5010
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Classification Product Code
FGE
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More FDA Info for this Product Code
Date Received
08/07/2003
Decision Date
02/04/2004
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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