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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 K080364
Device Name FINDRWIRZ GUIDE WIRE SYSTEM
Applicant
SENTREHEART INC.
2468 EMBARCADERO WAY
PALO ALTO,  CA  94303
Applicant Contact LINDA GUTHRIE
Correspondent
SENTREHEART INC.
2468 EMBARCADERO WAY
PALO ALTO,  CA  94303
Correspondent Contact LINDA GUTHRIE
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/11/2008
Decision Date 08/11/2008
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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