Asahi Gaia First, Second, Third
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133865 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 Gaia First, Second, Third is a Cardiac Occlusion Device designed for the temporary occlusion of the left atrial appendage (LAA) to reduce the risk of stroke in patients with non-valvular atrial fibrillation. It consists of a self-expanding nitinol wire mesh occluder with a delivery system, engineered to conform to the anatomical contours of the LAA while maintaining patency of the left atrial appendage orifice.
This device is supplied sterile and intended for single-use procedures. It is delivered via a catheter-based approach under fluoroscopic guidance and is approved for use in the United States under FDA 510K clearance (K133865) and complies with the MDD (Medical Device Directive). Available in three sizes (First, Second, Third), it is intended for percutaneous implantation in the LAA and requires post-procedural imaging to confirm proper positioning. Storage conditions include protection from moisture and extreme temperatures.
Frequently asked questions
What is the Asahi Gaia device used for in clinical practice?
The Asahi Gaia First, Second, and Third devices are designed to temporarily occlude the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation. By blocking the LAA, they aim to reduce the risk of stroke by preventing blood clots from forming and escaping into the bloodstream. The device is implanted percutaneously via a catheter under fluoroscopic guidance, conforming to the LAA’s shape while keeping the orifice open.
Are the Asahi Gaia devices reusable or single-use, and how should they be stored?
The Asahi Gaia devices are intended for single-use only and are supplied sterile. To maintain integrity, they must be stored in a dry environment, protected from moisture and extreme temperatures, as specified by the manufacturer.
What sizes are available for the Asahi Gaia device, and how are they determined?
The Asahi Gaia is available in three sizes—First, Second, and Third—each tailored to different anatomical contours of the left atrial appendage (LAA). The sizing is determined by the specific patient’s LAA morphology, ensuring proper occlusion while preserving orifice patency. Pre-procedural imaging is typically used to select the appropriate size.
How is the device implanted, and what follow-up is required after the procedure?
The Asahi Gaia device is implanted via a catheter-based approach under fluoroscopic guidance, allowing for precise placement within the LAA. After implantation, post-procedural imaging is required to confirm correct positioning and ensure the device is functioning as intended. This step is critical to verify occlusion while maintaining orifice patency.
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 | K133865 | Class II | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
Sources (2)
- FDA 510(k) K133865 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026