Merit MAK Nitinol/Gold-Tungsten Guide Wire
FDA 510(k) K261640 · Merit Medical Ireland , Ltd.
510(k) numberK261640
Submission
- Device name
- Merit MAK Nitinol/Gold-Tungsten Guide Wire
- Applicant
- Merit Medical Ireland , Ltd.
Galway, IE - Received
- May 18, 2026
- Decision date
- July 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
Other 510(k)s with product code DQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035DQX · Traditional | Filmecc Co., Ltd. | 09/03/2026SE |
| K253667 | Accoat Guide WireDQX · Traditional | Sp Medical A/S | 07/14/2026SE |
| K254137 | InQwire Amplatz Guide WireDQX · Traditional | Merit Medical Ireland, Ltd. | 05/22/2026SE |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | FMD Co., Ltd. | 03/20/2026SE |
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | Merit Medical Ireland, Ltd. | 01/31/2026SE |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
| K252674 | Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional | Solo Pace, Inc. | 01/09/2026SE |
| K251596 | Lunderquist Extra Stiff Wire GuideDQX · Special | William Cook Europe Aps | 11/09/2025SE |
More from William Cook Europe Aps
| 510(k) | Device | Decision |
|---|---|---|
| K254137 | InQwire Amplatz Guide WireDQX · Traditional | 05/22/2026SE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | 01/31/2026SE |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | 01/21/2026SE |
| K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire…DQX · Special | 08/29/2025SE |
| K122321 | Basixconpak Analog Inflation SyringeMAV · Traditional | 12/19/2012SE |
Questions and answers
When was Merit MAK Nitinol/Gold-Tungsten Guide Wire cleared by the FDA?
Merit MAK Nitinol/Gold-Tungsten Guide Wire (K261640) received a 510(k) decision of Substantially Equivalent on July 13, 2026, 56 days after the submission was received.
What is the product code of K261640?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.