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FDA 510(k) Application Details - K182302
Device Classification Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K182302
Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant
CardioGard Medical Ltd
6 Yoni Netanyahu Street
Or-Yehuda 6037604 IL
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Contact
Orit Ronan
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Regulation Number
870.4210
More FDA Info for this Regulation Number
Classification Product Code
DWF
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More FDA Info for this Product Code
Date Received
08/24/2018
Decision Date
05/17/2019
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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