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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 K031783
Device Name SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005
Applicant
Intravascular Incorporated
3600 Bur Wood Dr.
Waukegan,  IL  60085
Applicant Contact STEVE APERAVICH
Correspondent
Intravascular Incorporated
3600 Bur Wood Dr.
Waukegan,  IL  60085
Correspondent Contact STEVE APERAVICH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/10/2003
Decision Date 07/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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