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510(k) Premarket Notification Database

Device Classification Name:	CATHETER, BILIARY
Regulation Number:	876.5010 [See Other Products with this regulation number]
510(k) Number:	K032457
Device Name:	MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Applicant:	CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014
Contact:	SAM MIRZA
Product Code:	FGE [See Other Manufacturers that make this Product]
Date Received:	08-11-2003
Decision Date:	09-04-2003
Decision:	SU
Advisory Committee:	GU
Statement/Summary/Purged Status:	Summary
Type:	Special
Review by Third Party:	N
Expedited Review:	N

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