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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 K893460
Device Name A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM
Applicant
Therex Corp.
1600 Providence Hwy.
Walpole,  MA  02081
Applicant Contact J ENEGREN
Correspondent
Therex Corp.
1600 Providence Hwy.
Walpole,  MA  02081
Correspondent Contact J ENEGREN
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/03/1989
Decision Date 06/23/1989
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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