Merit Medical Ireland, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 2
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | January 31, 2026 |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire | January 21, 2026 |
| K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J | August 29, 2025 |
| K122321 | BASIXCONPAK ANALOG INFLATION SYRINGE | December 19, 2012 |