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FDA 510(k) Application Details - K093647
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K093647
Device Name
Wire, Guide, Catheter
Applicant
MICROVENTION, INC.
1311 VALENCIA AVE
TUSTIN, CA 92780 US
Other 510(k) Applications for this Company
Contact
Naomi Gong
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/25/2009
Decision Date
02/24/2010
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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