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FDA 510(k) Application Details - K132190
Device Classification Name
Valvulotome
More FDA Info for this Device
510(K) Number
K132190
Device Name
Valvulotome
Applicant
LEMAITRE VASCULAR, INC.
63 2ND AVENUE
BURLINGTON, MA 01803 US
Other 510(k) Applications for this Company
Contact
Anna Kasseris
Other 510(k) Applications for this Contact
Regulation Number
870.4885
More FDA Info for this Regulation Number
Classification Product Code
MGZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/15/2013
Decision Date
08/05/2013
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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