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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 K073241
Device Name VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM
Applicant
Vascular Pathways
713 Sandoval Way
Hayward,  CA  94544
Applicant Contact MARY PASCUAL GALLUP
Correspondent
Vascular Pathways
713 Sandoval Way
Hayward,  CA  94544
Correspondent Contact MARY PASCUAL GALLUP
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/16/2007
Decision Date 02/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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