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FDA 510(k) Application Details - K230065
Device Classification Name
More FDA Info for this Device
510(K) Number
K230065
Device Name
VenSureÖ Balloon Dilation System, VenSureÖ Light Balloon Dilation System, VenSureÖ Nav Balloon Dilation System, VenSureÖ ET Balloon Dilation System
Applicant
Fiagon GmbH
Neuendorfst. 23b
Hennigsdorf 16761 DE
Other 510(k) Applications for this Company
Contact
Dirk Mucha
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PNZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/09/2023
Decision Date
05/26/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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