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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K895597
Device Name VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER
Applicant
Vas-Cath, Inc.
2380 Tedlo St.
Mississauga, Ontario,  CA L5A 3V3
Applicant Contact H CREWE
Correspondent
Vas-Cath, Inc.
2380 Tedlo St.
Mississauga, Ontario,  CA L5A 3V3
Correspondent Contact H CREWE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/18/1989
Decision Date 09/12/1990
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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