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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K023548
Device Name PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101
Applicant
Velocimed
11400 73rd Ave. N. Suite 134
Minneapolis,  MN  55369
Applicant Contact JOHN CARLINE
Correspondent
Velocimed
11400 73rd Ave. N. Suite 134
Minneapolis,  MN  55369
Correspondent Contact JOHN CARLINE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/22/2002
Decision Date 08/04/2003
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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