20G X 1.25 NovaCath Secure IV Catheter System, 24G X 0.56 NovaCath Secure IV Catheter System

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 20g X 1.25 Novacath Secure Iv Catheter System, 24g X 0.56 Novacath Secure Iv Catheter System.

Pre-market Notification Details

• Device ID: K160374
• 510k Number: K160374
• Device Name: 20G X 1.25 NovaCath Secure IV Catheter System, 24G X 0.56 NovaCath Secure IV Catheter System
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: TANGENT MEDICAL TECHNOLOGIES, INC. 8170 JACKSON ROAD, STE A Ann Arbor, MI 48103
• Contact: Greg Last
• Correspondent: Greg Last; TANGENT MEDICAL TECHNOLOGIES, INC. 8170 JACKSON ROAD, STE A Ann Arbor, MI 48103
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-10
• Decision Date: 2016-03-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10887709090436	K160374	000