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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 K972762
Device Name CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES
Applicant
CARDIOMETRICS, INC.
645 CLYDE AVE.
MOUNTAIN VIEW,  CA  94043
Applicant Contact Claire Andrews
Correspondent
CARDIOMETRICS, INC.
645 CLYDE AVE.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact Claire Andrews
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/24/1997
Decision Date 10/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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