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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 K992880
Device Name P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
Applicant
SIMS DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Applicant Contact LISA J STONE
Correspondent
SIMS DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Correspondent Contact LISA J STONE
Regulation Number880.5965
Classification Product Code
LJT  
Date Received08/27/1999
Decision Date 10/19/1999
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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