Asahi Guide Wire Extension AG149000
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083145 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 Guide Wire Extension AG149000 is a guidewire extension device designed to facilitate the advancement of guidewires through complex or tortuous vascular anatomy. It is intended for use in percutaneous coronary interventions, enabling greater flexibility and reach for existing guidewires in coronary angiography and interventional cardiology procedures.
This device is supplied as a single-use, non-sterile product and is intended for use in controlled clinical settings such as catheterization laboratories. It is classified under product code DQX and has received FDA 510(k) clearance, MDD, and MDR authorizations. The extension is compatible with standard guidewire systems and is intended for use with MRI-safe imaging equipment, adhering to strict regulatory standards for medical devices.
Frequently asked questions
What is the primary purpose of the Asahi Guide Wire Extension AG149000 in clinical procedures?
The Asahi Guide Wire Extension AG149000 is specifically designed to help advance guidewires through challenging or winding blood vessels during coronary angiography and interventional cardiology procedures. Its purpose is to enhance flexibility and reach, allowing clinicians to navigate complex vascular anatomy more effectively during percutaneous coronary interventions.
Is the Asahi Guide Wire Extension AG149000 intended for reuse, or is it meant for single-use only?
The Asahi Guide Wire Extension AG149000 is explicitly supplied as a single-use device. This classification ensures patient safety and sterility in controlled clinical settings like catheterization labs, where it is intended for use.
How is the Asahi Guide Wire Extension AG149000 packaged and prepared for use in a clinical setting?
The device is supplied as a non-sterile product, meaning it must be sterilized by the facility prior to use. This is typical for single-use devices intended for controlled clinical environments like catheterization labs, where proper sterilization protocols are followed before deployment.
What regulatory pathways has the Asahi Guide Wire Extension AG149000 undergone, and which committee reviewed its submission?
The device has received FDA 510(k) clearance, MDD, and MDR authorizations. Its submission was reviewed by the Cardiovascular (CV) Advisory Committee under the Special clearance type, with a decision classified as Substantially Equivalent (SESE). The product code assigned is DQX, reflecting its classification in 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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K083145 | Class II | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
Sources (2)
- FDA 510(k) K083145 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026