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 |
|---|---|---|---|
| K260168 | Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) | Skycade Med Corporation | 2026-10-16 |
| K253146 | Hyperdrive 35 Guidewire | Rapid-Medical , Ltd. | 2026-09-18 |
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | Filmecc Co., Ltd. | 2026-09-03 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10193489077667 | NAMIC | MEDLINE INDUSTRIES, INC. | 2022-02-23 |
| 10193489078039 | NAMIC | MEDLINE INDUSTRIES, INC. | 2021-07-26 |
| 00389701007908 | GLIDEACCESS | TERUMO MEDICAL CORPORATION | 2016-09-24 |
| 00827002314535 | Lunderquist | William Cook Europe ApS | 2016-09-24 |
| 00389701007953 | GLIDEACCESS | TERUMO MEDICAL CORPORATION | 2016-09-24 |
| 00389701007946 | GLIDEACCESS | TERUMO MEDICAL CORPORATION | 2016-09-24 |
| 00389701007939 | GLIDEACCESS | TERUMO MEDICAL CORPORATION | 2016-09-24 |
| 00389701007922 | GLIDEACCESS | TERUMO MEDICAL CORPORATION | 2016-09-24 |
| 00389701007915 | GLIDEACCESS | TERUMO MEDICAL CORPORATION | 2016-09-24 |
| 10801902124521 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902124507 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902124491 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902124484 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902124460 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902124378 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902124361 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902124354 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902124538 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 00801902030672 | ARROW | TELEFLEX INCORPORATED | 2016-09-15 |
| 00801902002419 | ARROW | TELEFLEX INCORPORATED | 2016-09-15 |
| 00801902002402 | ARROW | TELEFLEX INCORPORATED | 2016-09-15 |
| 00886333216284 | Guidewire | ARGON MEDICAL DEVICES, INC. | 2016-09-12 |
| 00886333211906 | Guidewire | ARGON MEDICAL DEVICES, INC. | 2016-09-12 |
| 00886333211166 | Guidewire | ARGON MEDICAL DEVICES, INC. | 2016-09-12 |
| 08717648079627 | ACCESSORIES | ABBOTT VASCULAR INC. | 2016-08-05 |
| 08717648013980 | ACCESSORIES | ABBOTT VASCULAR INC. | 2016-08-05 |
| 08717648013331 | ACCESSORIES | ABBOTT VASCULAR INC. | 2016-08-05 |
| 08717648013324 | INTRODUCER | ABBOTT VASCULAR INC. | 2016-08-05 |
| 00801902002181 | ARROW | TELEFLEX INCORPORATED | 2016-02-05 |
| 00801902002174 | ARROW | TELEFLEX INCORPORATED | 2016-02-05 |