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FDA 510(k) Application Details - K040345
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K040345
Device Name
Wire, Guide, Catheter
Applicant
EV3 INC
4600 NATHAN LN. NORTH
PLYMOUTH, MN 55442-2920 US
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Contact
CAROLYN ANDERSON
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
02/12/2004
Decision Date
03/02/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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