510(k) K180177
- Device
- Guidewire
- Applicant
- Shanghai Kindly Medical Instruments Co., Ltd.
- 510(k) number
- K180177
- Product code
- DQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-09-13
- Date received
- 2018-01-22
- Regulation
- 870.1330
- Classification name
- Wire, Guide, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code DQX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 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 |
Legacy Summary#
summary
FDA Review#
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