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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, Long-Term Greater Than 30 Days
510(k) Number K892926
Device Name DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS
Applicant
Vas-Cath, Inc.
2380 Tedio St.
Mississauga,Ontario,  CA L5A3V3
Applicant Contact KATHERINE CREWE
Correspondent
Vas-Cath, Inc.
2380 Tedio St.
Mississauga,Ontario,  CA L5A3V3
Correspondent Contact KATHERINE CREWE
Regulation Number880.5970
Classification Product Code
LJS  
Date Received04/21/1989
Decision Date 12/05/1989
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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