Product code DQX
- Device name
- Wire, Guide, Catheter
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1330
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253667 | Accoat Guide Wire | Sp Medical A/S | 2026-07-14 |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland , Ltd. | 2026-07-13 |
| K254137 | InQwire Amplatz Guide Wire | Merit Medical Ireland, Ltd. | 2026-05-22 |
| K260544 | 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 | FMD Co., Ltd. | 2026-03-20 |
| 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 ... | 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 Guid... | 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 |
| K241521 | Prelude Small O.D. Introducer Guide Wire | Merit Medical Systems, Inc. | 2024-12-10 |
| K242824 | PTFE Guidewire | Lake Region Medical | 2024-12-06 |
| K240818 | R2P Radifocus Glidewire Advantage | Terumo Corporation | 2024-11-26 |
| K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL | 2024-11-06 |
| K241784 | Arrow® Nitinol Wire | Teleflex Medical | 2024-09-18 |
| K240859 | Glidewire GT-R | Terumo Corporation | 2024-08-21 |
| K241510 | CROSSLEAD Tracker | Asahi Intecc Co., Ltd. | 2024-08-14 |
| K240387 | MINAMO blue; MINAMO viola | Asahi Intecc Co., Ltd. | 2024-06-21 |
| K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) | FMD Co., Ltd. | 2024-06-13 |
| K240864 | PacePro Wire | Opsens, Inc. | 2024-05-24 |
| K232662 | BNLE Hydrophilic Jacketed Peripheral Guidewire | Biomerics Nle | 2024-05-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884450739709 | InQwire® | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450731789 | InQwire® | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450529300 | SplashWire™ | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450529713 | SplashWire™ | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450529829 | SplashWire™ | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450590010 | SplashWire™ | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450631928 | InQwire® Amplatz | Merit Medical Systems, Inc. | 2026-08-21 |
| 10801902226430 | ARROW | TELEFLEX INCORPORATED | 2026-08-10 |
| 10801902226065 | ARROW | TELEFLEX INCORPORATED | 2026-05-08 |
| 00843152100057 | IOPS Visionary System | Centerline Biomedical, Inc. | 2026-02-24 |
| 10801902210637 | ARROW | TELEFLEX INCORPORATED | 2023-06-21 |
| 10801902202984 | ARROW | TELEFLEX INCORPORATED | 2023-06-06 |
| 10801902210620 | ARROW | TELEFLEX INCORPORATED | 2023-06-06 |
| 10801902210613 | ARROW | TELEFLEX INCORPORATED | 2023-06-06 |
| 10801902210590 | ARROW | TELEFLEX INCORPORATED | 2023-06-06 |
| 10801902210583 | ARROW | TELEFLEX INCORPORATED | 2023-06-06 |
| 10801902203073 | ARROW | TELEFLEX INCORPORATED | 2023-06-06 |
| 10801902203103 | ARROW | TELEFLEX INCORPORATED | 2022-12-02 |
| 10801902203011 | ARROW | TELEFLEX INCORPORATED | 2022-11-09 |
| 10801902203042 | ARROW | TELEFLEX INCORPORATED | 2022-11-09 |
| 10801902202991 | ARROW | TELEFLEX INCORPORATED | 2022-11-09 |
| 10801902210576 | ARROW | TELEFLEX INCORPORATED | 2022-11-09 |
| 10801902199512 | ARROW | TELEFLEX INCORPORATED | 2022-11-09 |
| 10801902199345 | ARROW | TELEFLEX INCORPORATED | 2022-11-09 |
| 10801902199307 | ARROW | TELEFLEX INCORPORATED | 2022-11-09 |
| 04719875599033 | EpiFaith CV | Flat Medical Co., Ltd. | 2022-10-26 |
| 10801902203028 | ARROW | TELEFLEX INCORPORATED | 2022-04-29 |
| 04251244500436 | MRWire Guidewire | Contract Medical International GmbH | 2018-08-07 |
| 04251244500429 | MRWire Guidewire | Contract Medical International GmbH | 2018-08-07 |
| 10801902124354 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |