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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Carotid Catheter For Embolic Capture
510(k) Number K111987
Device Name FIBERNET EMBOLIC PROTECTION DEVICE
Applicant
Lumen Biomedical, Inc.
10900 73rd Ave. N.
Suite 150
Maple Grove,  MN  55369
Applicant Contact MICHELLE STRAIGHT
Correspondent
Lumen Biomedical, Inc.
10900 73rd Ave. N.
Suite 150
Maple Grove,  MN  55369
Correspondent Contact MICHELLE STRAIGHT
Regulation Number870.1250
Classification Product Code
NTE  
Date Received07/13/2011
Decision Date 08/17/2011
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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