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FDA 510(k) Application Details - K972623
Device Classification Name
Catheter, Embolectomy
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510(K) Number
K972623
Device Name
Catheter, Embolectomy
Applicant
LUCAS MEDICAL, INC.
1751 SOUTH DOUGLASS RD.
ANAHEIM, CA 92806 US
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Contact
DANIEL LUCAS
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Regulation Number
870.5150
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Classification Product Code
DXE
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More FDA Info for this Product Code
Date Received
07/14/1997
Decision Date
11/19/1997
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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