FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
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)
K Number: K251385
·
Decision Jan 21, 2026
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
5
Review Days
261
Basic Information
- Device Name
- 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)
- K Number
- K251385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merit Medical Ireland, Ltd.
- Date Received
- May 5, 2025
- Decision Date
- January 21, 2026
- Product Code
- DQX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Merit Medical Ireland, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K254137 | InQwire Amplatz Guide Wire | May 22, 2026 | Substantially Equivalent |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Jan 31, 2026 | Substantially Equivalent |
| 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) | Aug 29, 2025 | Substantially Equivalent |
| K122321 | BASIXCONPAK ANALOG INFLATION SYRINGE | Dec 19, 2012 | Substantially Equivalent |