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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 K932010
Device Name V.A.D. ACCESS KIT
Applicant
Clinipad Corp.
66 High St.
P.O. Box 387
Guilford,  CT  06437
Applicant Contact PATRICIA STAWARZ
Correspondent
Clinipad Corp.
66 High St.
P.O. Box 387
Guilford,  CT  06437
Correspondent Contact PATRICIA STAWARZ
Regulation Number880.5965
Classification Product Code
LJT  
Date Received04/23/1993
Decision Date 02/03/1994
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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