PacePro Wire
FDA 510(k) K240864 · Opsens, Inc.
510(k) numberK240864
Submission
- Device name
- PacePro Wire
- Applicant
- Opsens, Inc.
Quebec, CA - Received
- March 28, 2024
- Decision date
- May 24, 2024
- 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
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| 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 |
| 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 |
| K152991 | OptoWire DeuxDQX · Traditional | 02/11/2016SE |
| K142598 | Opto Wire and OptoMonitor SystemDQX · Traditional | 06/12/2015SE |
Questions and answers
When was PacePro Wire cleared by the FDA?
PacePro Wire (K240864) received a 510(k) decision of Substantially Equivalent on May 24, 2024, 57 days after the submission was received.
What is the product code of K240864?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.