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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 K051062
Device Name VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO
Applicant
FLOWCARDIA, INC.
745 N. PASTORIA AVE.
SUNNYVALE,  CA  94085
Applicant Contact RICHARD SPANO
Correspondent
FLOWCARDIA, INC.
745 N. PASTORIA AVE.
SUNNYVALE,  CA  94085
Correspondent Contact RICHARD SPANO
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/26/2005
Decision Date 07/15/2005
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
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