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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 K875214
Device Name A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
Applicant
Therex Corp.
1600 Providence Hwy.
Walpole,  MA  02081
Applicant Contact BRADLEY ENEGREN
Correspondent
Therex Corp.
1600 Providence Hwy.
Walpole,  MA  02081
Correspondent Contact BRADLEY ENEGREN
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/18/1987
Decision Date 02/19/1988
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
Recalls CDRH Recalls
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