Asahi Sion PTCA Guide Wire 180CMJ, 300CMJ
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122469 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 Sion PTCA Guide Wire is a coronary guidewire designed for percutaneous transluminal coronary angioplasty (PTCA). It is engineered to facilitate the navigation of catheters and balloons through coronary arteries, aiding in the treatment of coronary artery disease by restoring blood flow to obstructed vessels.
These guide wires are supplied sterile and intended for single-use in interventional cardiology procedures. The 180CMJ and 300CMJ lengths are available, with the device classified under product code DQX. Authorized under FDA 510K clearance and the Medical Device Directive (MDD), they are intended for use in controlled clinical settings such as cardiac catheterization labs. Storage should follow manufacturer guidelines to maintain sterility.
Frequently asked questions
What are the primary uses of the Asahi Sion PTCA Guide Wire in a clinical setting?
The Asahi Sion PTCA Guide Wire is specifically designed for percutaneous transluminal coronary angioplasty (PTCA), a procedure used to treat coronary artery disease. It helps guide catheters and balloons through narrowed or blocked coronary arteries to restore blood flow, improving circulation to the heart muscle.
Are these guide wires reusable, or are they intended for single-use only?
The Asahi Sion PTCA Guide Wire is explicitly intended for single-use in interventional cardiology procedures. This ensures sterility and safety for each patient, reducing the risk of contamination or cross-infection.
What lengths are available for the Asahi Sion PTCA Guide Wire, and how might this affect procedure planning?
The Asahi Sion PTCA Guide Wire is available in two lengths: 180 cm and 300 cm. The choice of length depends on the patient’s anatomy and the specific needs of the procedure, such as the depth of the coronary arteries or the complexity of the blockage being treated.
How should these guide wires be stored to maintain their sterility and usability?
The Asahi Sion PTCA Guide Wire is supplied sterile, so storage must follow the manufacturer’s guidelines to preserve sterility. This typically involves keeping the packaging intact, avoiding exposure to moisture or contamination, and storing in a clean, dry environment until use.
What regulatory pathways have been followed for this device, and how does that impact its use?
The Asahi Sion PTCA Guide Wire has received FDA 510(k) clearance and complies with the Medical Device Directive (MDD). This means it has undergone regulatory review to ensure safety and effectiveness for its intended use in controlled clinical settings, such as cardiac catheterization labs, under the guidance of trained interventional cardiologists.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K122469 | Class II | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
Sources (2)
- FDA 510(k) K122469 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026