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FDA 510(k) Application Details - K223891
Device Classification Name
More FDA Info for this Device
510(K) Number
K223891
Device Name
Cobra Catheter System
Applicant
Endovascular Engineering
3925 Bohannon Drive, Suite 300
Menlo Park, CA 94025 US
Other 510(k) Applications for this Company
Contact
Debra Cogan
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/27/2022
Decision Date
02/15/2023
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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