Hi Torque Connect Guidewire, Hi Torque Connect Flex Guidewire, Hi Torque Connect 250T Guidewire
FDA 510(k) K140536 · Lake Region Medical
510(k) numberK140536
Submission
- Device name
- Hi Torque Connect Guidewire, Hi Torque Connect Flex Guidewire, Hi Torque Connect 250T Guidewire
- Applicant
- Lake Region Medical
Galway, IE - Received
- March 4, 2014
- Decision date
- December 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
| 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 |
More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | 03/19/2026SE |
| K242824 | PTFE GuidewireDQX · Special | 12/06/2024SE |
| K221575 | Pre-Formed BlueDQX · Traditional | 10/07/2022SE |
| K211741 | Pre-Formed Extra Support GuidewireDQX · Traditional | 11/22/2021SE |
| K160643 | ENROUTE 0.014 GuidewireDQX · Traditional | 10/18/2016SE |
| K151244 | Pre-Formed GuidewireDQX · Special | 06/11/2015SE |
| K142393 | Predicate III GuidewireDQX · Special | 11/25/2014SE |
| K142397 | Predicate III GuidewireOCY · Special | 09/19/2014SE |
| K140482 | Mandrel GuidewireOCY · Special | 04/08/2014SE |
| K133155 | Hydrophilic Coated GuidewireDQX · Traditional | 04/07/2014SE |
Questions and answers
When was Hi Torque Connect Guidewire, Hi Torque Connect Flex Guidewire, Hi Torque Connect 250T Guidewire cleared by the FDA?
Hi Torque Connect Guidewire, Hi Torque Connect Flex Guidewire, Hi Torque Connect 250T Guidewire (K140536) received a 510(k) decision of Substantially Equivalent on December 17, 2014, 288 days after the submission was received.
What is the product code of K140536?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.