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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 K880571
Device Name CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
Applicant
Catheter Technology Corp.
3385 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact JACK SPEER
Correspondent
Catheter Technology Corp.
3385 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact JACK SPEER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received02/10/1988
Decision Date 03/04/1988
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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