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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) Number K081417
Device Name FOXCROSS PTA CATHETER
Applicant
ABBOTT VASCULAR INC.
3200 Lakeside Drive
Santa Clara,  CA  95054
Applicant Contact NADINE SMITH
Correspondent
ABBOTT VASCULAR INC.
3200 Lakeside Drive
Santa Clara,  CA  95054
Correspondent Contact NADINE SMITH
Regulation Number870.1250
Classification Product Code
LIT  
Date Received05/20/2008
Decision Date 06/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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