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FDA 510(k) Application Details - K053265
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K053265
Device Name
Wire, Guide, Catheter
Applicant
MICRUS ENDOVASCULAR CORPORATION
610 PALOMAR AVENUE
SUNNYVALE, CA 94085 US
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Contact
MARGARET WEBBER
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
11/22/2005
Decision Date
04/28/2006
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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