MEDI-TRACE

Catheter, Continuous Flush

GRAPHIC CONTROLS CORP.

The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace.

Pre-market Notification Details

• Device ID: K811410
• 510k Number: K811410
• Device Name: MEDI-TRACE
• Classification: Catheter, Continuous Flush
• Applicant: GRAPHIC CONTROLS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KRA
• CFR Regulation Number: 870.1210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-05-19
• Decision Date: 1981-06-12