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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K033726
Device Name PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER
Applicant
Precision Vascular
2405 W. Orton Circle
West Valley City,  UT  84119
Applicant Contact RICK GAYKOWSKI
Correspondent
Precision Vascular
2405 W. Orton Circle
West Valley City,  UT  84119
Correspondent Contact RICK GAYKOWSKI
Regulation Number870.1210
Classification Product Code
KRA  
Date Received11/28/2003
Decision Date 01/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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