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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 K923882
Device Name IV-TUBE SECURE
Applicant
Ximedix, Inc.
2802 Delta Dr.
Colorado Springs,  CO  80910
Applicant Contact FRANK D SULARZ
Correspondent
Ximedix, Inc.
2802 Delta Dr.
Colorado Springs,  CO  80910
Correspondent Contact FRANK D SULARZ
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/04/1992
Decision Date 12/24/1992
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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