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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K032146
Device Name PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
Applicant
Precision Vascular Systems, Inc.
2405 W. Orton Cir.
West Valley City,  UT  84119
Applicant Contact RICK GAYKOWSKI
Correspondent
Precision Vascular Systems, Inc.
2405 W. Orton Cir.
West Valley City,  UT  84119
Correspondent Contact RICK GAYKOWSKI
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/14/2003
Decision Date 08/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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