NOVACATH SECURE IV CATHETER SYSTEM-18G

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

TANGENT MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Tangent Medical Technologies, Inc. with the FDA for Novacath Secure Iv Catheter System-18g.

Pre-market Notification Details

• Device ID: K120839
• 510k Number: K120839
• Device Name: NOVACATH SECURE IV CATHETER SYSTEM-18G
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: TANGENT MEDICAL TECHNOLOGIES, INC. 8170 JACKSON RD, STE A Ann Arbor, MI 48103
• Contact: Kay Fuller
• Correspondent: Kay Fuller; TANGENT MEDICAL TECHNOLOGIES, INC. 8170 JACKSON RD, STE A Ann Arbor, MI 48103
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-20
• Decision Date: 2012-07-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10887709121581	K120839	000
10887709090368	K120839	000
10887709090221	K120839	000
10887709086590	K120839	000