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Merit Medical Ireland , Ltd.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K261640 Merit MAK Nitinol/Gold-Tungsten Guide WireDQX2026-07-13 View
510(k) K254137 InQwire Amplatz Guide WireDQX2026-05-22 View
510(k) K253847 Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX2026-01-31 View
510(k) K251385 InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)DQX2026-01-21 View
510(k) K251181 Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)DQX2025-08-29 View
510(k) K122321 BASIXCONPAK ANALOG INFLATION SYRINGEMAV2012-12-19 View
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