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FDA 510(k) Application Details - K080364
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K080364
Device Name
Wire, Guide, Catheter
Applicant
SENTREHEART INC.
2468 EMBARCADERO WAY
PALO ALTO, CA 94303 US
Other 510(k) Applications for this Company
Contact
LINDA GUTHRIE
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/11/2008
Decision Date
08/11/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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