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FDA 510(k) Application Details - K022145
Device Classification Name
Catheter, Embolectomy
More FDA Info for this Device
510(K) Number
K022145
Device Name
Catheter, Embolectomy
Applicant
LEMAITRE VASCULAR, INC.
26 RAY AVE.
BURLINGTON, MA 01803 US
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Contact
JAMES ASHBY
Other 510(k) Applications for this Contact
Regulation Number
870.5150
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Classification Product Code
DXE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/02/2002
Decision Date
01/14/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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