Total clearances
5
2025-08-29 → 2026-07-13
Name variants in FDA filings: Merit Medical Ireland, Ltd. / Merit Medical Ireland , Ltd.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| DQX |
Wire, Guide, Catheter |
Class II |
Cardiovascular |
5 |
2026-07-13 |
Filings
All 510(k) clearances (5)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-07-13 |
K261640 |
Merit MAK Nitinol/Gold-Tungsten Guide Wire |
DQX |
Class II |
Cardiovascular |
| 2026-05-22 |
K254137 |
InQwire Amplatz Guide Wire |
DQX |
Class II |
Cardiovascular |
| 2026-01-31 |
K253847 |
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) |
DQX |
Class II |
Cardiovascular |
| 2026-01-21 |
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) |
DQX |
Class II |
Cardiovascular |
| 2025-08-29 |
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) |
DQX |
Class II |
Cardiovascular |