Latis Graft Cleaning Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K973465 FDA 510(k)
- FDA Product Code
- DXE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5150 FDA 510(k)
- Regulation Number
- 870.5150 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Latis Graft Cleaning Catheter is an embolectomy catheter designed for the removal of thromboemboli from vascular grafts. It functions as a mechanical tool that also facilitates graft occlusion and fluid infusion.
This single-use, disposable device is operated by clinicians in a clinical setting. It is authorized under FDA 510(k) clearance K973465.
Frequently asked questions
What is the primary function of the Latis Graft Cleaning Catheter?
This device is designed as a mechanical embolectomy catheter used for the removal of thromboemboli from vascular grafts. Additionally, it is engineered to facilitate graft occlusion and fluid infusion during clinical procedures.
Is the Latis Graft Cleaning Catheter intended for multiple uses?
No, this is a single-use, disposable device. It is intended to be used once in a clinical setting to ensure patient safety and maintain the integrity of the mechanical components.
What is the regulatory status of this device?
The Latis Graft Cleaning Catheter is authorized under FDA 510(k) clearance K973465. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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: Applied Medical Resources Latis Graft Cleaning Catheter Kits - CATHETER ..., LATIS GRAFT CLEANING CATHETER (K973465) — FDA 510(k) | Innolitics, K973465 - LATIS GRAFT CLEANING CATHETER | FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K973465 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources
Sources (1)
- FDA 510(k) K973465 24 fields · synced Sep 22, 2026