CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS

Catheter, Intravascular, Diagnostic

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis 5.0 French Super Torque Catheters.

Pre-market Notification Details

• Device ID: K915836
• 510k Number: K915836
• Device Name: CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS
• Classification: Catheter, Intravascular, Diagnostic
• Applicant: CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014
• Contact: Katherine Trevisol
• Correspondent: Katherine Trevisol; CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014
• Product Code: DQO
• CFR Regulation Number: 870.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-12-24
• Decision Date: 1992-02-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10705032030779	K915836	000
10705032045025	K915836	000
10705032045032	K915836	000
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