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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 K921475
Device Name A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM
Applicant
THEREX CORP.
1600 PROVIDENCE HIGHWAY
WALPOLE,  MA  02081
Applicant Contact BRADLEY J ENEGREN
Correspondent
THEREX CORP.
1600 PROVIDENCE HIGHWAY
WALPOLE,  MA  02081
Correspondent Contact BRADLEY J ENEGREN
Regulation Number880.5965
Classification Product Code
LJT  
Date Received03/30/1992
Decision Date 10/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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