Identifiers
- 510(k) Number
- K213868 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 Gladius Mongo18 PV ES is a peripheral guidewire classified under the Device Type Guidewire, Peripheral and designed for use in vascular procedures. It features a 0.018-inch diameter with a polymer jacket, providing enhanced steerability and support for navigating and treating stenosed lesions, particularly in below-the-knee and above-the-knee arteries. The ES variant incorporates extra support for improved push force and stability during deployment.
This guidewire is supplied as a single-use, non-sterile device intended for use in controlled clinical settings such as catheterization labs. It is compatible with MRI environments as specified by its design and materials, though users must confirm compatibility with their specific MRI system. The device is authorized under FDA 510K and MDR regulations, adhering to strict manufacturing and performance standards. Storage requires protection from physical damage and contamination, with no specified shelf-life limitations stated in the data.
Frequently asked questions
What types of vascular procedures is the ASAHI Gladius Mongo18 PV ES guidewire specifically designed to assist with, and why does the 'ES' variant stand out?
The ASAHI Gladius Mongo18 PV ES is designed to navigate and treat stenosed lesions in both below-the-knee and above-the-knee arteries, where precise steerability and support are critical. The 'ES' variant includes extra support, enhancing push force and stability during deployment—ideal for challenging cases where additional rigidity improves wire performance in tight or tortuous vessels.
Is this guidewire reusable, or is it intended for single-use only? How does that affect its clinical workflow?
The ASAHI Gladius Mongo18 PV ES is explicitly labeled as a single-use device, meaning it is not meant to be reused after a single procedure. This design choice aligns with controlled clinical settings like catheterization labs, where sterility and contamination risks are minimized by adhering to single-patient use protocols, reducing the need for reprocessing and ensuring consistent performance.
Can this guidewire be used in MRI environments, and what precautions should clinicians take when doing so?
Yes, the ASAHI Gladius Mongo18 PV ES is MRI-compatible by design and materials, but clinicians must verify compatibility with their specific MRI system before use. While the wire itself is engineered for MRI environments, individual facility protocols and system specifications may vary, so pre-procedure checks are essential to avoid interference or safety risks.
What storage conditions are recommended for this guidewire, and are there any limitations on shelf life?
The device should be stored in a way that protects it from physical damage and contamination, though no explicit shelf-life limitations are stated in the data. Since it is supplied non-sterile, it is intended for use in sterile clinical environments (e.g., catheterization labs), where terminal sterilization occurs just prior to procedure. Always follow facility protocols for handling non-sterile medical devices.
How does the 0.018-inch diameter and polymer jacket of this guidewire benefit clinicians during vascular procedures?
The 0.018-inch diameter provides a balance of flexibility and strength, allowing the guidewire to navigate smaller or more delicate vessels while still offering sufficient support. The polymer jacket enhances steerability and reduces friction, making it easier to maneuver through stenosed or tortuous arteries—particularly useful in below-the-knee and above-the-knee regions where traditional guidewires may struggle with stability or control.
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: ASAHI Gladius® Mongo® 18 PV ES | Asahi Intecc Medical, ASAHI Gladius MG18 PV ES - ASAHI INTECC MEDICAL PRODUCTS, ASAHI Gladius® Mongo® / Mongo® ES coronary guide wire | Asahi Intecc ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213868 | Class II | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
Sources (2)
- FDA 510(k) K213868 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026