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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 Rd.
Suite A
Ann Arbor,  MI  48103
Applicant Contact GREG LAST
Correspondent
Tangent Medical Technologies, Inc.
8170 Jackson Rd.
Suite 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
Predetermined Change
Control Plan Authorized		 No
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