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FDA 510(k) Application Details - K980723
Device Classification Name
Valvulotome
More FDA Info for this Device
510(K) Number
K980723
Device Name
Valvulotome
Applicant
VASCUTECH, INC.
164 MIDDLESEX TURNPIKE
BURLINGTON, MA 01803 US
Other 510(k) Applications for this Company
Contact
GEORGE W LEMAITRE
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
02/24/1998
Decision Date
02/12/1999
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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