FDA 510(k) Application Details - K193507

Device Classification Name	Device, Percutaneous Retrieval   More FDA Info for this Device
510(K) Number	K193507
Device Name	Device, Percutaneous Retrieval
Applicant	Merit Medical Systems, Inc. Parkmore Business Park West Galway IE Other 510(k) Applications for this Company
Contact	Mark Mullaney Other 510(k) Applications for this Contact
Regulation Number	870.5150   More FDA Info for this Regulation Number
Classification Product Code	MMX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2019
Decision Date	01/17/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review