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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K992532
Device Name VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
Applicant
BAXTER HEALTHCARE CORP.
17221 RED HILL AVE.
PO BOX 11150
IRVINE,  CA  92614 -5627
Applicant Contact JASON SMITH
Correspondent
BAXTER HEALTHCARE CORP.
17221 RED HILL AVE.
PO BOX 11150
IRVINE,  CA  92614 -5627
Correspondent Contact JASON SMITH
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/29/1999
Decision Date 06/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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