OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202543 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)
The OmniWire Pressure Guide Wire is a guidewire designed for use in coronary and peripheral vascular interventions. It combines pressure-sensing capabilities with steerable tip configurations to facilitate precise catheter navigation and pressure measurement within blood vessels, aiding in diagnostic and interventional procedures.
This device is supplied as a single-use guidewire and is intended for use in electrophysiology and interventional cardiology settings. The 185 cm length and dual tip options (straight or J-tip) enhance maneuverability in complex vascular anatomies. Authorized under FDA 510(k) clearance (K202543) and MDD compliance, it adheres to cardiovascular device standards for interventional use.
Frequently asked questions
What types of procedures is the OmniWire Pressure Guide Wire designed to assist with, and how does its design help in those settings?
The OmniWire Pressure Guide Wire is designed for coronary and peripheral vascular interventions, particularly in electrophysiology and interventional cardiology. Its pressure-sensing capability allows for real-time measurement of vascular pressures, which aids in precise catheter navigation and accurate assessment of lesion severity or vessel resistance. The dual tip options—straight or J-tip—provide enhanced maneuverability in complex vascular anatomies, making it useful for both diagnostic and interventional procedures where flexibility and precision are critical.
Is the OmniWire Pressure Guide Wire reusable, and if not, what are the implications for clinical workflow?
No, the OmniWire Pressure Guide Wire is explicitly supplied as a single-use device. This design choice ensures sterility and reduces the risk of contamination or damage between uses, which is particularly important in sterile environments like electrophysiology labs or catheterization suites. Clinicians should follow standard single-use protocols, including proper disposal after use and avoiding reuse to maintain safety and compliance with medical device regulations.
What length options are available for the OmniWire Pressure Guide Wire, and how might this affect its use in different patients?
The OmniWire Pressure Guide Wire is available in a single length of 185 cm, which is designed to accommodate both coronary and peripheral vascular procedures. The extended length provides greater reach for navigating longer or tortuous vessels, while the steerable tip configurations (straight or J-tip) further enhance adaptability. This fixed length ensures consistency in performance but may require clinicians to select the appropriate tip style based on the specific anatomy or procedural needs of the patient.
How is the OmniWire Pressure Guide Wire authorized for use, and what regulatory standards does it comply with?
The OmniWire Pressure Guide Wire is authorized under FDA 510(k) clearance (K202543) and complies with the Medical Device Directive (MDD). The clearance was granted through the Cardiovascular (CV) Advisory Committee under a Special 510(k) review, with a decision code of SESE (Substantially Equivalent). This means it meets the regulatory requirements for cardiovascular guidewires and adheres to standards for interventional use, ensuring its safety and effectiveness for the intended applications in electrophysiology and interventional cardiology.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K202543 | Class II | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
Sources (2)
- FDA 510(k) K202543 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026