Asahi Astato 30 Peripheral Guide Wire, Models - Pagh18m071, Pagh18m371
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071721 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 Asahi Astato 30 Peripheral Guide Wire is a peripheral guidewire designed for use in cardiovascular procedures. It provides support and navigation within blood vessels, facilitating the placement of catheters or other interventional devices during peripheral vascular interventions.
This device is supplied sterile and intended for single-use. It is classified under the FDA Product Code DQX and authorized via FDA 510K clearance (K071721) under the Medical Device Reporting (MDR) and Medical Device Directive (MDD) frameworks. The models PAGH18M071 and PAGH18M371 are available, with no specific MRI safety or reusable indications stated.
Frequently asked questions
What are the key differences between the PAGH18M071 and PAGH18M371 models of the Asahi Astato 30 Peripheral Guide Wire?
The provided data does not specify any functional, structural, or performance differences between the PAGH18M071 and PAGH18M371 models of the Asahi Astato 30 Peripheral Guide Wire. Both models are listed under the same device description and specifications, indicating they may share identical technical characteristics. For precise distinctions, such as tip design, coating, or length, you would need to consult the manufacturer’s detailed product documentation or contact Asahi Intecc Co., Ltd. directly.
Is the Asahi Astato 30 Peripheral Guide Wire safe to use in MRI environments, and if not, why?
The Asahi Astato 30 Peripheral Guide Wire does not have any explicit MRI safety labeling or indication in the provided data. Since it is a metallic device, it may pose risks in MRI environments due to potential heating, torque, or imaging artifacts. Always verify compatibility with your MRI system and follow institutional protocols for non-MRI-condemned devices. Consult the manufacturer’s instructions for use or contact Asahi Intecc Co., Ltd. for clarification.
How should the Asahi Astato 30 Peripheral Guide Wire be stored, and what are the implications of its single-use designation?
The Asahi Astato 30 Peripheral Guide Wire is supplied sterile and intended for single-use only, meaning it should not be reused after a single procedure. Storage instructions are not detailed in the provided data, but generally, sterile guidewires should be kept in a clean, dry environment, protected from contamination, and within the manufacturer’s specified shelf life. Always follow the manufacturer’s guidelines to maintain sterility and integrity until use.
What regulatory pathways does the Asahi Astato 30 Peripheral Guide Wire follow, and how does this affect its use in clinical settings?
The Asahi Astato 30 Peripheral Guide Wire is authorized via FDA 510(k) clearance (K071721) under the Medical Device Reporting (MDR) framework, classified under FDA Product Code DQX (Guidewires, Peripheral). It is also compliant with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in the EU. This clearance indicates the device is deemed substantially equivalent to a predicate device and meets regulatory standards for safety and effectiveness. Clinicians should ensure the device is used within its intended clinical context as described in the manufacturer’s instructions.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K071721 | Class II | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
Sources (2)
- FDA 510(k) K071721 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026