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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Steerable
510(k) Number K112239
Device Name STEERABLE GUIDE CATHETER
Applicant
Abbott Vascular
4045 Campbell Ave.
Menlo Park,  CA  94025
Applicant Contact CYNTHIA MORROW
Correspondent
Abbott Vascular
4045 Campbell Ave.
Menlo Park,  CA  94025
Correspondent Contact CYNTHIA MORROW
Regulation Number870.1280
Classification Product Code
DRA  
Date Received08/04/2011
Decision Date 08/31/2011
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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