CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM

Dilator, Vessel, For Percutaneous Catheterization

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Avanti+catheter Sheath Introducer System.

Pre-market Notification Details

• Device ID: K970392
• 510k Number: K970392
• Device Name: CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
• Classification: Dilator, Vessel, For Percutaneous Catheterization
• Applicant: CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014
• Contact: Elena S Jugo
• Correspondent: Elena S Jugo; CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014
• Product Code: DRE
• CFR Regulation Number: 870.1310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-02-03
• Decision Date: 1997-04-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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