Medical Device Manufacturer · US , South Jordan , UT

Merit Medical Systems, Inc.

177 submissions · 169 cleared · Since 1988
177
Total
169
Cleared
0
Denied

Merit Medical Systems, Inc. — FDA 510(k) Submissions

Merit Medical Systems, Inc. has submitted 177 FDA 510(k) premarket notifications since 1988, of which 169 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wire, Guide, Catheter, Introducer, Catheter, Syringe, Piston, Circuit, Breathing (w Connector, Adaptor, Y Piece), Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass . Use the specialty filter in the sidebar to narrow results.

177 devices
1–25 of 177
STAR RF Ablation System
K251802 · GXI Probe, Radiofrequency Lesion · Neurology
Feb 2026 246d
SCOUT MD Surgical Guidance System
K252892 · NEU Marker, Radiographic,... · General & Plastic Surgery
Dec 2025 99d
Merit Syringe
K250853 · FMF Syringe, Piston · General Hospital
Nov 2025 228d
Resilience Fully Covered Esophageal Stent System
K251265 · ESW Prosthesis, Esophageal · Gastroenterology & Urology
Jul 2025 90d
Prelude Wave Hydrophilic Sheath Introducer
K250909 · DYB Introducer, Catheter · Cardiovascular
Apr 2025 30d
Micro Ace Gold Advanced Micro Access System
K242229 · DRE Dilator, Vessel, For... · Cardiovascular
Jan 2025 169d
Ventrax? Delivery System
K242873 · DQY Catheter, Percutaneous · Cardiovascular
Jan 2025 114d
Prelude Small O.D. Introducer Guide Wire
K241521 · DQX Wire, Guide, Catheter · Cardiovascular
Dec 2024 195d
Impress Angiographic Catheter
K233268 · DQO Catheter, Intravascular,... · Cardiovascular
May 2024 236d
Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)
K240261 · KRD Device, Vascular, For... · Cardiovascular
May 2024 92d
Bearing nsPVA Express?
K233813 · NAJ Agents, Embolic, For... · Obstetrics & Gynecology
Dec 2023 21d
Mighty Wire Guide Wire
K230418 · DQX Wire, Guide, Catheter · Cardiovascular
Oct 2023 254d
Micro Ace? Advanced Micro Access System
K232609 · DRE Dilator, Vessel, For... · Cardiovascular
Sep 2023 30d
Ventrax? Delivery System (VTR851)
K231246 · DQY Catheter, Percutaneous · Cardiovascular
Aug 2023 121d
Aspira Pleural Drainage System
K212696 · DWM Apparatus, Suction,... · Anesthesiology
Mar 2023 555d
Low Profile Companion Sheath
K223872 · DYB Introducer, Catheter · Cardiovascular
Jan 2023 27d
HeRO Graft
K213845 · DSY Prosthesis, Vascular... · Cardiovascular
Aug 2022 249d
SCOUT BX Delivery System
K212882 · NEU Marker, Radiographic,... · General & Plastic Surgery
Apr 2022 210d
Elation Pulmonary Balloon Dilation Catheter
K213434 · KTI Bronchoscope Accessory · Ear, Nose, Throat
Mar 2022 137d
Aspira Peritoneal Drainage System
K212675 · PNG Peritoneal, Drainage... · Gastroenterology & Urology
Dec 2021 112d
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
K212199 · QEZ Aspiration Thrombectomy... · Cardiovascular
Nov 2021 112d
Prelude Guide Sheath
K211405 · DYB Introducer, Catheter · Cardiovascular
Oct 2021 151d
SwiftNINJA Steerable Microcatheter
K211525 · KRA Catheter, Continuous Flush · Cardiovascular
Jul 2021 60d
HeRO Graft, HeRO Adapter
K203724 · DSY Prosthesis, Vascular... · Cardiovascular
May 2021 155d
Cultura Collection and Transport System
K201674 · JSM Culture Media,... · Microbiology
Mar 2021 257d

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