Disposable Torque Device
FDA 510(k) K113498 · Coeur, Inc.
510(k) numberK113498
Submission
- Device name
- Disposable Torque Device
- Applicant
- Coeur, Inc.
Lebanon, TN, US - Received
- November 25, 2011
- Decision date
- July 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…DXT · Traditional | 08/18/2017SE |
| K161471 | MR Syringe Dual Pack for Solaris InjectorsDXT · Traditional | 10/06/2016SE |
| K150902 | 330psi Extension Y-Line with Dual Check ValveDXT · Traditional | 10/22/2015SE |
| K142745 | 125mL CT SyringeDXT · Traditional | 04/01/2015SE |
| K140469 | MR Syringe Dual PackDXT · Traditional | 07/28/2014SE |
| K133600 | Coeur, Inc. Frontload for Optivantage Power InjectorDXT · Traditional | 04/30/2014SE |
| K120892 | Disposable 330PSI Extension LinesDXT · Traditional | 06/10/2013SE |
| K113132 | Disposable Hemostatic Y-ConnectorsDTL · Traditional | 01/20/2012SE |
| K090487 | Disposable Angiographic Syringes for Use with Nemoto Angiographic Power, Model SY-125…DXT · Traditional | 10/19/2009SE |
| K070798 | Adapters for CT, Angiographic, And/Or MRI Power InjectorsDXT · Traditional | 10/04/2007SE |
Questions and answers
When was Disposable Torque Device cleared by the FDA?
Disposable Torque Device (K113498) received a 510(k) decision of Substantially Equivalent on July 20, 2012, 238 days after the submission was received.
What is the product code of K113498?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.