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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 K050964
Device Name PV 1900 SYNCHRO 0.016 GUIDEWIRE
Applicant
BOSTON SCIENTIFIC - PRECISION VASCULAR
2405 WEST ORTON CIR.
WEST VALLEY CITY,  UT  84119
Applicant Contact RICK GAYKOWSKI
Correspondent
BOSTON SCIENTIFIC - PRECISION VASCULAR
2405 WEST ORTON CIR.
WEST VALLEY CITY,  UT  84119
Correspondent Contact RICK GAYKOWSKI
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/18/2005
Decision Date 06/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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