Medical Device Manufacturer · IE , Galway

Merit Medical System, Inc. - FDA 510(k) Cleared Devices

5 submissions · 4 cleared · Since 2020
5
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Merit Medical System, Inc. Cardiovascular ✕
4 devices
1-4 of 4
Cleared CT Sep 10, 2025
Surfacer Inside-Out Access Catheter System
K252527 · QJH
Cardiovascular · 30d
Cleared Mar 30, 2023
Maestro Microcatheter
K230636 · KRA
Cardiovascular · 23d
Cleared Dec 15, 2021
Merit Siege Vascular Plug
K212817 · KRD
Cardiovascular · 103d
Cleared Apr 08, 2020
Go2Wire Guide Wire
K193571 · DQX
Cardiovascular · 107d
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All5 Cardiovascular 4 General & Plastic Surgery 1