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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 K072824
Device Name FOX SV PTA CATHETER
Applicant
Abbott Laboratories
3200 Lakeside Dr.
Santa Clara,  CA  95054
Applicant Contact GEORGE J PRENDERGAST
Correspondent
Abbott Laboratories
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent Contact GEORGE J PRENDERGAST
Regulation Number870.1250
Classification Product Code
LIT  
Date Received10/02/2007
Decision Date 10/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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