510(k) K260544
- Device
- FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40
- Applicant
- FMD Co., Ltd.
- 510(k) number
- K260544
- Product code
- DQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-20
- Date received
- 2026-02-18
- Regulation
- 870.1330
- Classification name
- Wire, Guide, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Mayumi Ito
- Address
- 1-57-7 Sasazuka Shibuya-Ku JP 151-0073 151-0073
FDA Registration Numbers
- 3010665433
- 1450662
- 3014499739
- 2184149
- 2133928
- 2248146
- 2521402
- 3003289691
- 3012050423
- 9617592
- 1061124
- 9616662
- 3018784828
- 3008307705
- 3005737652
- 2183870
- 3011564431
- 3007635982
- 3015453963
- 3008002401
- 3010291427
- 2183744
- 3012536737
- 3009039068
- 3013023134
- 3010882065
- 1644312
- 2134265
- 1018470
- 1030451
- 3009957947
- 3013611763
- 3024682301
- 2025587
- 3012497308
- 3015550451
- 3005012805
- 3030447506
- 3010163695
- 3039642752
- 3011050570
- 3001124136
- 9610139
- 3013557562
- 2024168
- 3010131137
- 9612812
- 9616684
- 1225687
- 1423537
- 1721676
- 1820334
- 2939561
- 3015910259
- 2017865
- 3036802499
- 3007284006
- 3006425876
- 3013750125
- 3006950086
- 3033589330
- 3008439199
- 3013162291
- 1824619
- 3000247873
- 3017210488
- 3017636737
- 2024024
- 3002807314
- 3007628272
- 2126666
- 3012159165
- 1293141
- 3003915875
- 1018233
- 3008403546
- 3014716786
- 1417485
- 3003084417
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code DQX
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253746 | Enroute 0.014'' Transcarotid Guidewire | Lake Region Medical | 2026-03-19 |
| K253262 | EmeryGlide (EG18008901) | Nano4imaging GmbH | 2026-03-06 |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. | 2026-01-31 |
| 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) | Merit Medical Ireland, Ltd. | 2026-01-21 |
| K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | 2026-01-09 |
| K251596 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | 2025-11-09 |
| K250203 | SureAx-Guide | Sureax Medical, LLC | 2025-10-17 |
| K250031 | Amplatzer Guidewire | ABBOTT MEDICAL | 2025-10-03 |
| 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) | Merit Medical Ireland, Ltd. | 2025-08-29 |
| K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL | 2025-07-25 |
| K250075 | Medtronic Stedi Extra Support Guidewire | Medtronic, Inc. | 2025-06-13 |
| K243733 | SION blue PLUS | Asahi Intecc Co., Ltd. | 2025-04-02 |
| K241962 | Crossloop | Asahi Intecc Co., Ltd. | 2025-03-27 |
| K242597 | CROSSLEAD 0.018inch | Asahi Intecc Co., Ltd. | 2025-03-05 |
| K241702 | CROSSLEAD 0.014inch | Asahi Intecc Co., Ltd. | 2025-02-06 |