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FDA 510(k) Application Details - K964161
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
510(K) Number
K964161
Device Name
Clamp, Vascular
Applicant
HEARTPORT, INC.
200 CHESAPEAKE DR.
REDWOOD CITY, CA 94063 US
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Contact
KEVIN F MACDONALD
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
10/17/1996
Decision Date
04/04/1997
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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