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FDA 510(k) Application Details - K180904
Device Classification Name
Catheter, Intravascular Occluding, Temporary
More FDA Info for this Device
510(K) Number
K180904
Device Name
Catheter, Intravascular Occluding, Temporary
Applicant
Embolx, Inc
530 Lakeside, Suite 200
Sunnyvale, CA 94085 US
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Contact
Greg Haistead
Other 510(k) Applications for this Contact
Regulation Number
870.4450
More FDA Info for this Regulation Number
Classification Product Code
MJN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/06/2018
Decision Date
06/08/2018
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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