FDA 510(k) Application Details - K212675

Device Classification Name	More FDA Info for this Device
510(K) Number	K212675
Device Name	Aspira Peritoneal Drainage System
Applicant	Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	Jennifer Webb Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2021
Decision Date	12/14/2021
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review