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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 K953571
Device Name VASPORT VASCULAR ACCESS PORT
Applicant
Gish Biomedical, Inc.
2681 Kelvin Ave.
Irvine,  CA  92614
Applicant Contact DEBRA J KRIDNER
Correspondent
Gish Biomedical, Inc.
2681 Kelvin Ave.
Irvine,  CA  92614
Correspondent Contact DEBRA J KRIDNER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received07/31/1995
Decision Date 10/02/1995
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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