Medical Device Manufacturer · US , South Jordan , UT

Merit Medical Ireland, Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2012

Recent clearances: InQwire Amplatz Guide Wire, Splashwire Hydrophilic Guide Wire (MSWSTD35150J3), InQwire Super Stiff Guide Wire (IQSS32180J3)

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Merit Medical Ireland, Ltd. Cardiovascular ✕

6 devices

1-6 of 6

Cleared Jul 13, 2026

Merit MAK Nitinol/Gold-Tungsten Guide Wire

Cardiovascular · 56d

Cleared May 22, 2026

InQwire Amplatz Guide Wire

Cardiovascular · 151d

Cleared Jan 31, 2026

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

Cardiovascular · 60d

Cleared Jan 21, 2026

InQwire Super Stiff Guide Wire (IQSS32180J3)

Cardiovascular · 261d

Cleared Aug 29, 2025

Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5)

Cardiovascular · 135d

Cleared Dec 19, 2012

BASIXCONPAK ANALOG INFLATION SYRINGE

Cardiovascular · 140d

Data Source

Sourced from the FDA 510(k) public files . 175,730 total devices indexed.

Last updated: Aug 06, 2026