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FDA 510(k) Application Details - K080169
Device Classification Name
Clamp, Vascular
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510(K) Number
K080169
Device Name
Clamp, Vascular
Applicant
GUIDANT CORPORATION, CARDIAC SURGERY
170 BAYTECH DRIVE
SAN JOSE, CA 95134 US
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Contact
ELIZABETH TRUJILLO
Other 510(k) Applications for this Contact
Regulation Number
870.4450
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Classification Product Code
DXC
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More FDA Info for this Product Code
Date Received
01/24/2008
Decision Date
02/08/2008
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
Y
Expedited Review
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