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FDA 510(k) Application Details - K201872
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K201872
Device Name
Set, Administration, Intravascular
Applicant
Asset Medikal Tasarim AS.
Ikitelli OSB Mahallesi, 17. Cadde, No: 17
Istanbul 34490 TR
Other 510(k) Applications for this Company
Contact
Ebru Sirali
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/07/2020
Decision Date
01/05/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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