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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 K971619
Device Name MICROFUSE MEMBRANE INFUSION CATHETER
Applicant
E-Med Corp.
651 Campus Dr.
Saint Paul,  MN  55112
Applicant Contact JOHN DOCKTER
Correspondent
E-Med Corp.
651 Campus Dr.
Saint Paul,  MN  55112
Correspondent Contact JOHN DOCKTER
Regulation Number870.1210
Classification Product Code
KRA  
Date Received05/01/1997
Decision Date 02/27/1998
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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