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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K160374
Device Name 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System
Applicant
TANGENT MEDICAL TECHNOLOGIES, INC.
8170 JACKSON ROAD, STE A
ANN ARBOR,  MI  48103
Applicant Contact GREG LAST
Correspondent
TANGENT MEDICAL TECHNOLOGIES, INC.
8170 JACKSON ROAD, STE A
ANN ARBOR,  MI  48103
Correspondent Contact GREG LAST
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/10/2016
Decision Date 03/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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