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FDA 510(k) Application Details - K140438
Device Classification Name
More FDA Info for this Device
510(K) Number
K140438
Device Name
MICRO GUIDE CATHETER ELITE
Applicant
CORDIS CORP., A JOHNSON & JOHNSON CO.
6500 PASEO PADRE PKWY.
FREMONT, CA 94555 US
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Contact
Michelle Ragozzine Rodgers
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PDU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/21/2014
Decision Date
11/14/2014
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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