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FDA 510(k) Application Details - K191606
Device Classification Name
Catheter, Intravascular Occluding, Temporary
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510(K) Number
K191606
Device Name
Catheter, Intravascular Occluding, Temporary
Applicant
RenovoRx, Inc.
4546 El Camino Real, Suite 223
Los Altos, CA 94022 US
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Contact
Kamran Najmabadi
Other 510(k) Applications for this Contact
Regulation Number
870.4450
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Classification Product Code
MJN
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More FDA Info for this Product Code
Date Received
06/17/2019
Decision Date
08/07/2019
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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