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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K875213
Device Name SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE
Applicant
Titan Medical, Inc.
1306 W. County Rd. F, #201
Arden Hills,  MN  55112
Applicant Contact ROBERT LEE
Correspondent
Titan Medical, Inc.
1306 W. County Rd. F, #201
Arden Hills,  MN  55112
Correspondent Contact ROBERT LEE
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/18/1987
Decision Date 03/03/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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