FDA 510(k) Application Details - K182538

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K182538
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	Merit Medical Singapore Pte. Ltd. 198 Yishun Avenue 7 Singapore 768926 SG Other 510(k) Applications for this Company
Contact	Xing Ting Seow 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	09/14/2018
Decision Date	01/16/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review