FDA 510(k) Application Details - K221827

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K221827
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	Saudi Mais Co. for Medical Products 256 Third Industrial Area Riyadh 14335-7599 SA Other 510(k) Applications for this Company
Contact	Salman Rashid Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2022
Decision Date	06/23/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review