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FDA 510(k) Application Details - K080863
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K080863
Device Name
Wire, Guide, Catheter
Applicant
MICROVENTION, INC.
75 COLUMBIA
SUITE A
ALISO VIEJO, CA 92656-1408 US
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Contact
KEVIN E DALY
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
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More FDA Info for this Product Code
Date Received
03/28/2008
Decision Date
04/17/2008
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
Y
Expedited Review
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