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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 K991897
Device Name CATHETER INNOVATIONS IMPLANTABLE PORT
Applicant
CATHETER INNOVATIONS, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact ROGER L RICHINS
Correspondent
CATHETER INNOVATIONS, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact ROGER L RICHINS
Regulation Number880.5965
Classification Product Code
LJT  
Date Received06/04/1999
Decision Date 10/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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