EmboGuide
by Philips Medical Systems Nederland B.V.
510(k) K142273
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK142273 | Date30 Jan 2015 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- OWB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The EmboGuide is an interventional fluoroscopic X-ray system designed for guiding and visualising catheter-based procedures. It provides real-time imaging to assist in the navigation of embolic materials, such as coils or occlusive devices, within vascular structures during interventions like stroke treatment or peripheral embolisation.
This device is supplied as a reusable system and is intended for use in radiology settings. It operates under sterile conditions when used for invasive procedures and is compatible with MRI-safe environments as specified by its design. The system is authorised under FDA 510K and MDR regulations, with a classification as a Class II medical device. Storage and handling follow manufacturer guidelines to ensure proper functionality and sterility.
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Questions
AI-generated answers, 18 Sep 2026
What types of procedures is the EmboGuide primarily used to assist with, and how does it provide support during these interventions?
The EmboGuide is designed to guide and visualize catheter-based procedures, particularly those involving embolic materials like coils or occlusive devices. It provides real-time fluoroscopic X-ray imaging, which helps clinicians navigate these materials within vascular structures during critical interventions such as stroke treatment (e.g., mechanical thrombectomy) or peripheral embolization. The system ensures precise visualization, enabling accurate placement of embolic materials to treat blockages or abnormalities.
Is the EmboGuide system reusable, and if so, what considerations should be taken into account for its maintenance and sterility during use?
Yes, the EmboGuide is supplied as a reusable system. Since it is used in invasive procedures, it must be maintained under sterile conditions to prevent contamination. The manufacturer provides guidelines for storage and handling to ensure proper functionality and sterility, which includes regular cleaning, disinfection, and inspection to comply with clinical and regulatory standards.
Can the EmboGuide be used in environments where MRI compatibility is a concern, and how does this feature benefit clinical workflows?
Yes, the EmboGuide is designed to be compatible with MRI-safe environments. This feature allows clinicians to perform procedures in settings where MRI compatibility is critical, reducing the need for patient transfers or additional imaging modalities. It streamlines workflows by ensuring seamless integration with MRI-compatible facilities, particularly useful in complex cases requiring multi-modal imaging.
What regulatory pathways has the EmboGuide followed, and what does this mean for its use in clinical settings?
The EmboGuide has been authorized through the FDA 510K pathway and the EU’s Medical Device Regulation (MDR), classifying it as a Class II medical device. This means it has undergone rigorous evaluation to demonstrate substantial equivalence to a predicate device (for FDA) and compliance with EU safety, performance, and regulatory requirements. Clinicians can rely on its regulatory status as evidence of its safety and effectiveness for guiding catheter-based procedures in radiology settings.