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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K011646
Device Name NEUROEDGE INFUSION CATHETER
Applicant
Neuro Vasx, Inc.
7351 Kirkwood Ln., Suite 112
Maple Grove,  MN  55369
Applicant Contact JACK SLOVICK
Correspondent
Neuro Vasx, Inc.
7351 Kirkwood Ln., Suite 112
Maple Grove,  MN  55369
Correspondent Contact JACK SLOVICK
Regulation Number870.1210
Classification Product Code
KRA  
Date Received05/29/2001
Decision Date 08/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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