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FDA 510(k) Application Details - K002143
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K002143
Device Name
Catheter, Biliary, Diagnostic
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA, CA 95054-2807 US
Other 510(k) Applications for this Company
Contact
SUSAN SILAVIN, PH.D.
Other 510(k) Applications for this Contact
Regulation Number
876.5010
More FDA Info for this Regulation Number
Classification Product Code
FGE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/17/2000
Decision Date
10/12/2000
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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