Merit Medical Ireland, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: InQwire Amplatz Guide Wire, Splashwire Hydrophilic Guide Wire (MSWSTD35150J3), InQwire Super Stiff Guide Wire (IQSS32180J3)
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Merit Medical Ireland, Ltd. Cardiovascular ✕
5 devices
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