OptoWire Deux
FDA 510(k) K152991 · Opsens
510(k) numberK152991
Submission
- Device name
- OptoWire Deux
- Applicant
- Opsens
Quebec, CA - Received
- October 13, 2015
- Decision date
- February 11, 2016
- 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 |
|---|---|---|
| K251367 | OptoMonitor 3DXO · Traditional | 01/16/2026SE |
| K241418 | OptoMonitor 3DXO · Traditional | 02/12/2025SE |
| K240864 | PacePro WireDQX · Traditional | 05/24/2024SE |
| K213854 | SavvyWireDQX · Traditional | 09/14/2022SE |
| K202943 | OptoMonitor 3DXO · Traditional | 11/24/2020SE |
| K193620 | OptoMonitor 3DXO · Traditional | 06/18/2020SE |
| K191907 | OptoWire IIIDQX · Traditional | 01/02/2020SE |
| K192340 | OptoMonitorDXO · Traditional | 12/12/2019SE |
| K161263 | OptoMonitor IIDXO · Traditional | 09/13/2016SE |
| K142598 | Opto Wire and OptoMonitor SystemDQX · Traditional | 06/12/2015SE |
Questions and answers
When was OptoWire Deux cleared by the FDA?
OptoWire Deux (K152991) received a 510(k) decision of Substantially Equivalent on February 11, 2016, 121 days after the submission was received.
What is the product code of K152991?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.