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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K180994
Device Name SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
Applicant
Interrad Medical, Inc.
181 Cheshire Ln., Suite 100
Plymouth,  MN  55441
Applicant Contact Denise Lenz
Correspondent
Libramedical, Inc.
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Correspondent Contact Denise Lenz
Regulation Number880.5210
Classification Product Code
KMK  
Date Received04/16/2018
Decision Date 07/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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