CORTRAK

Tubes, Gastrointestinal (and Accessories)

VIASYS MEDSYSTEMS

The following data is part of a premarket notification filed by Viasys Medsystems with the FDA for Cortrak.

Pre-market Notification Details

• Device ID: K041987
• 510k Number: K041987
• Device Name: CORTRAK
• Classification: Tubes, Gastrointestinal (and Accessories)
• Applicant: VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090
• Contact: Stephanie Wasielewski
• Correspondent: Stephanie Wasielewski; VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090
• Product Code: KNT
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-07-23
• Decision Date: 2004-12-17