Asahi PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163426 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 PTCA, Peripheral, and Neurovascular Guide Wires are steerable guide wires featuring a core wire with coil assembly and a radiopaque distal tip for visibility. These devices are designed to facilitate placement and exchange of catheters and interventional devices in PTCA, PTA, and peripheral vascular procedures.
The Asahi Guide Wire Extension is supplied as part of the Asahi PTCA, Peripheral, and Neurovascular Guide Wires system. This device has received FDA 510(k) clearance with the product code DQX and is classified under the cardiovascular advisory committee. The device is intended for use in various vascular procedures requiring guidewire support and navigation.
Frequently asked questions
What is the ASAHI Guide Wire Extension used for?
The ASAHI Guide Wire Extension is designed to facilitate placement and exchange of catheters and interventional devices in PTCA, PTA, and peripheral vascular procedures. It features a core wire with coil assembly and a radiopaque distal tip for visibility during navigation.
How is the ASAHI Guide Wire Extension supplied?
The ASAHI Guide Wire Extension is supplied as part of the Asahi PTCA, Peripheral, and Neurovascular Guide Wires system. It is designed to work in conjunction with other components of this system for optimal performance in vascular procedures.
What regulatory clearance has the ASAHI Guide Wire Extension received?
The ASAHI Guide Wire Extension has received FDA 510(k) clearance with product code DQX and is classified under the cardiovascular advisory committee. It was determined to be substantially equivalent to predicate devices.
What are the key features of the ASAHI Guide Wire Extension?
The device features a steerable design with a core wire and coil assembly, plus a radiopaque distal tip for enhanced visibility during procedures. These features allow for precise navigation and support in various vascular interventions.
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 PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ..., ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ..., Asahi Intecc Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163426 | Class II | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
Sources (1)
- FDA 510(k) K163426 24 fields · synced Sep 22, 2026