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 Other 510(k) Applications for this Company
Contact	Chris Davey Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   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