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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 K112347
Device Name RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
Applicant
Vascular Pathways, Inc.
8 Snowberry Ct.
Orinda,  CA  94563
Applicant Contact MICHAEL A DANIEL
Correspondent
Vascular Pathways, Inc.
8 Snowberry Ct.
Orinda,  CA  94563
Correspondent Contact MICHAEL A DANIEL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/15/2011
Decision Date 09/22/2011
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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