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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 K053268
Device Name PVS 2000 SYNCHRO2 GUIDEWIRE
Applicant
Boston Scientific - Precision Vascular
2405 W. Orton Cir.
West Valley City,  UT  84119
Applicant Contact RICK GAYKOWSKI
Correspondent
Boston Scientific - Precision Vascular
2405 W. Orton Cir.
West Valley City,  UT  84119
Correspondent Contact RICK GAYKOWSKI
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/23/2005
Decision Date 03/13/2006
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
Recalls CDRH Recalls
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