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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 K872149
Device Name SURECATH-ITP PERCUTANEOUS ACCESS KIT
Applicant
Titan Medical, Inc.
1306 W. County Rd. F, #201
Arden Hills,  MN  55112
Applicant Contact JEFFREY M WILLIAMS
Correspondent
Titan Medical, Inc.
1306 W. County Rd. F, #201
Arden Hills,  MN  55112
Correspondent Contact JEFFREY M WILLIAMS
Regulation Number880.5965
Classification Product Code
LJT  
Date Received06/04/1987
Decision Date 08/04/1987
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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