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FDA 510(k) Application Details - K220632
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K220632
Device Name
Catheter, Percutaneous
Applicant
Marvao Medical Devices Ltd
Unit 1 Galway Business Park, Dangan
Galway H91A3EF IE
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Contact
Chris Davey
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Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
03/04/2022
Decision Date
06/02/2022
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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