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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, Intraperitoneal
510(k) Number K864552
Device Name PORT-A-CATH IMPLANTABLE CATHETER SYSTEM
Applicant
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854
Applicant Contact ALBERT P MAYO
Correspondent
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854
Correspondent Contact ALBERT P MAYO
Regulation Number880.5965
Classification Product Code
LLD  
Date Received11/19/1986
Decision Date 03/31/1987
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
Predetermined Change
Control Plan Authorized		 No
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