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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, embolectomy
510(k) Number K901625
Device Name FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
Applicant
BAXTER HEALTHCARE CORP.
17221 RED HILL AVE.
PO BOX 11150
IRVINE,  CA  92614 -5627
Applicant Contact VINCENT CUTARELLI
Correspondent
BAXTER HEALTHCARE CORP.
17221 RED HILL AVE.
PO BOX 11150
IRVINE,  CA  92614 -5627
Correspondent Contact VINCENT CUTARELLI
Regulation Number870.5150
Classification Product Code
DXE  
Date Received04/09/1990
Decision Date 07/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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