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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K925219
Device Name IVION ADMIN SETS W/FLOW CLIPS
Applicant
Ivion Corp.
2400 Industrial Ln.,
Suite 2000
Broomfield,  CO  80020
Applicant Contact AUDIE MARGRAVE
Correspondent
Ivion Corp.
2400 Industrial Ln.,
Suite 2000
Broomfield,  CO  80020
Correspondent Contact AUDIE MARGRAVE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/16/1992
Decision Date 07/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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