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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 K032754
Device Name VORTEX MP
Applicant
HORIZON MEDICAL PRODUCTS, INC.
1 HORIZON WAY
MANCHESTER,  GA  31816
Applicant Contact SCOTT MOELLER
Correspondent
HORIZON MEDICAL PRODUCTS, INC.
1 HORIZON WAY
MANCHESTER,  GA  31816
Correspondent Contact SCOTT MOELLER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/05/2003
Decision Date 09/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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