Identifiers
- 510(k) Number
- K240864 FDA 510(k)
- FDA Product Code
- DQX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
PacePro Wire is a sterile, single-use, unipolar guidewire used by physicians in clinical settings to navigate interventional devices through blood vessels into heart chambers. It functions as a structural guidewire and a temporary pacing electrode.
The device is supplied as a single-use item and is not for reuse. It is a Class 2 Cardiovascular device with product code DQX, cleared through the Traditional 510(k) pathway after a 57-day FDA review.
Frequently asked questions
What is the PacePro Wire used for?
PacePro Wire is used by physicians to navigate interventional devices through blood vessels into heart chambers. It functions as both a structural guidewire and a temporary pacing electrode in clinical settings.
Is the PacePro Wire reusable?
No, the PacePro Wire is supplied as a single-use item and is not intended for reuse. It must be discarded after a single procedure to ensure patient safety and device integrity.
What is the regulatory status of the PacePro Wire?
The PacePro Wire is a Class 2 Cardiovascular device with product code DQX, cleared through the Traditional 510(k) pathway after a 57-day FDA review with K number K240864.
How is the PacePro Wire supplied?
The PacePro Wire is supplied as a sterile, single-use device. It comes ready for use in clinical settings without requiring additional sterilization before procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PacePro Wire (K240864) — FDA 510 (k) | Innolitics, K240864 FDA 510 (k) - PacePro Wire | Opsens, Inc., PacePro Wire 510 (k) K240864 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240864 | Class II | Active |
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Manufacturer
- Manufacturer
- Opsens Inc.
- FDA Applicant
- Opsens, Inc.
Sources (1)
- FDA 510(k) K240864 24 fields · synced Sep 25, 2026