LMI Arterial Embolectomy Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K954760 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 LMI Arterial Embolectomy Catheter is a catheter, embolectomy designed for the removal of arterial emboli during surgical procedures. It is classified under the FDA’s product code DXE and falls within the cardiovascular device category. This device is intended for intraoperative use to clear blockages in arteries, facilitating blood flow restoration.
Supplied as a single-use device, the catheter is manufactured by Lucas Medical Inc. and holds FDA 510(k) clearance (K954760) under the traditional review pathway, with a classification of Class II (moderate risk). It adheres to regulatory standards including ISO 13485:2016 and is intended for use in controlled surgical environments. No MRI safety or reusable specifications are noted in the regulatory data.
Frequently asked questions
What is the LMI Arterial Embolectomy Catheter used for?
The LMI Arterial Embolectomy Catheter is designed specifically for the removal of arterial emboli during surgical procedures. Emboli are blockages in the arteries that can impede blood flow, and this catheter helps clear those blockages to restore proper circulation. It is intended for intraoperative use, meaning it is used while the patient is under surgery, ensuring immediate intervention when blockages occur.
Is the LMI Arterial Embolectomy Catheter single-use or reusable?
The LMI Arterial Embolectomy Catheter is supplied as a single-use device. This design ensures sterility and safety for each patient, as reusing medical devices can introduce risks of contamination or damage. Single-use devices are also aligned with regulatory standards to minimize infection risks in clinical settings.
What regulatory standards does the LMI Arterial Embolectomy Catheter meet?
The catheter meets ISO 13485:2016 quality management system standards, which ensure the device is manufactured under controlled conditions to maintain consistency and safety. Additionally, it holds FDA 510(k) clearance (K954760) under the traditional review pathway, confirming it is substantially equivalent to a legally marketed predicate device and classified as Class II (moderate risk).
How is the LMI Arterial Embolectomy Catheter supplied, and what should be considered for storage?
The catheter is supplied as a sterile, single-use device, packaged for immediate intraoperative use. Storage should follow manufacturer guidelines to preserve sterility and functionality. Typically, this involves keeping the device in its original packaging, away from direct sunlight, extreme temperatures, and moisture. Ensure the packaging remains intact until use to prevent contamination.
Does the LMI Arterial Embolectomy Catheter have any specific size or model variations?
The provided data does not specify individual size or model variations for the LMI Arterial Embolectomy Catheter. However, like many catheters, it may come in different lengths or diameters to accommodate various anatomical or procedural needs. For precise sizing information, refer to the product packaging or consult the manufacturer’s technical documentation, as these details are critical for proper selection and use.
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: PDF LMI Brochure - Embolectomy - Lucas Medical Extrusion, Home - Lucas Medical Inc, LMI ARTERIAL EMBOLECTOMY CATHETER — FDA Class II Medical Device ..., LMI ARTERIAL EMBOLECTOMY CATHETER (K954760) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954760 | Class II | Active |
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Manufacturer
- Manufacturer
- Lucas Medical Inc
- FDA Applicant
- Lucas Medical, Inc.
Sources (1)
- FDA 510(k) K954760 24 fields · synced Oct 1, 2026