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FDA 510(k) Application Details - K232190
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K232190
Device Name
Catheter, Percutaneous
Applicant
Medtronic Vascular
37A Cherry Hill Drive
Danvers, MA 01923 US
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Contact
Colleen Gentile
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
07/24/2023
Decision Date
08/22/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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