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FDA 510(k) Application Details - K111490
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
510(K) Number
K111490
Device Name
Catheter, Continuous Flush
Applicant
EV3 INC
173 JEFFERSON DR
MENLO PARK, CA 94025 US
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Contact
DANIEL CHER, MD
Other 510(k) Applications for this Contact
Regulation Number
870.1210
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Classification Product Code
KRA
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More FDA Info for this Product Code
Date Received
05/31/2011
Decision Date
09/16/2011
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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