Identifiers
- 510(k) Number
- K121611 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Amplatzer TorqVue FX is a catheter delivery system designed for the precise deployment of Amplatzer devices. It is classified as a cardiovascular occlusion device, intended for use in the treatment of congenital heart defects and vascular abnormalities through minimally invasive procedures.
This device is supplied as a reusable system with two delivery configurations: 45 and 180 degrees. It is intended for use in clinical settings such as cardiac catheterization labs, with sterility maintained through single-use components and proper handling protocols. The Amplatzer TorqVue FX holds an FDA 510(k) clearance under the traditional review pathway, ensuring compliance with regulatory standards for cardiovascular devices.
Frequently asked questions
What types of procedures is the Amplatzer TorqVue FX catheter delivery system designed to assist with, and where would it typically be used?
The Amplatzer TorqVue FX is specifically designed for the precise deployment of Amplatzer devices during minimally invasive procedures to treat congenital heart defects and vascular abnormalities. It is intended for use in clinical settings like cardiac catheterization labs, where specialized equipment and trained personnel perform these interventions.
Is the Amplatzer TorqVue FX system reusable, and if so, how is sterility maintained during use?
Yes, the Amplatzer TorqVue FX is supplied as a reusable system. Sterility is maintained through the use of single-use components and adherence to proper handling protocols, ensuring a clean environment for each procedure while extending the lifespan of the reusable parts.
What are the two delivery configurations available for the Amplatzer TorqVue FX, and how might they impact procedure planning?
The Amplatzer TorqVue FX comes in two delivery configurations: 45 degrees and 180 degrees. These configurations allow clinicians to choose the optimal angle for device deployment based on the patient’s anatomy and the specific requirements of the procedure, improving precision and flexibility during catheterization.
How was the Amplatzer TorqVue FX evaluated by the FDA, and what does the clearance status indicate about its regulatory compliance?
The Amplatzer TorqVue FX received FDA clearance under the traditional review pathway (510(k)) and was determined to be substantially equivalent to a legally marketed predicate device. This clearance indicates that the device meets regulatory standards for cardiovascular occlusion systems and complies with safety and effectiveness requirements for minimally invasive cardiac 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: AGA Medical AMPLATZER TorqVue Instructions For Use, AGA Medical AMPLATZER TorqVue Instructions For Use, Abbott Amplatzer TorqVue Instructions For Use - ManualsLib, AMPLATZER TORQVUE FX by AGA MEDICAL CORPORATION | FDA 510(k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121611 | Class II | Active |
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Manufacturer
- Manufacturer
- Aga Medical Corporation
Sources (1)
- FDA 510(k) K121611 24 fields · synced Oct 6, 2026