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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 K840481
Device Name INFUSE-A-PORT HEPARIN LOCK MAINT KIT
Applicant
Infusaid Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Infusaid Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5965
Classification Product Code
LJT  
Date Received02/06/1984
Decision Date 09/18/1984
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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