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FDA 510(k) Application Details - K001258
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K001258
Device Name
Catheter, Biliary, Diagnostic
Applicant
CORDIS CORP.
7 POWDER HORN DR.
WARREN, NJ 07059 US
Other 510(k) Applications for this Company
Contact
DEAN A KNIGHT
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
04/18/2000
Decision Date
06/27/2000
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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