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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K920036
Device Name SURECATH PORT ACCESS CATHETER
Applicant
Ivion Corp.
2400 Industrial Ln.,
Suite 2000
Broomfield,  CO  80020
Applicant Contact DOTTIE SEULEAN
Correspondent
Ivion Corp.
2400 Industrial Ln.,
Suite 2000
Broomfield,  CO  80020
Correspondent Contact DOTTIE SEULEAN
Regulation Number880.5965
Classification Product Code
LJT  
Date Received01/06/1992
Decision Date 11/25/1992
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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