510(k) K173548

Merit Pursue Microcatheter by Merit Medical Systems, Inc. — Product Code DQY

K173548 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Merit Pursue Microcatheter". The FDA issued a decision of Substantially Equivalent on Mar 30, 2018. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 30, 2018
Date Received
Nov 16, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type
510(k)