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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.
P.O. Box 11150
Irvine,  CA  92614 -5627
Applicant Contact VINCENT CUTARELLI
Correspondent
Baxter Healthcare Corp
17221 Red Hill Ave.
P.O. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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