CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM

Stents, Drains And Dilators For The Biliary Ducts

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Palmaz Genesis Transhepatic Billary Stent On Opta Pro .035 Delivery System.

Pre-market Notification Details

• Device ID: K033394
• 510k Number: K033394
• Device Name: CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
• Classification: Stents, Drains And Dilators For The Biliary Ducts
• Applicant: CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059
• Contact: Karen Wilk
• Correspondent: Karen Wilk; CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059
• Product Code: FGE
• CFR Regulation Number: 876.5010 [🔎]
• Decision: Se - With Limitations (SESU)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-10-23
• Decision Date: 2003-12-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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