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Lmi Irrigation Catheter (IGR)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K972623

by Lucas Medical Inc

Identifiers

510(k) Number
K972623 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 Irrigation Catheter (IGR) is a Class II catheter classified for cardiovascular use and identified as a catheter, embolectomy device. It is designed for intra‑operative flushing of arterial or venous vessels following thrombectomy procedures, delivering fluid through its lumen to clear residual thrombus.

The device is supplied as a single‑use, stainless‑steel wire‑reinforced silicone tube with a rounded leading nose, a female luer connector, strain relief, and four side ports each containing a central lumen for fluid delivery. It is cleared under FDA 510(k) number K972623 and is intended for sterile, disposable use in the operating room.

Frequently asked questions

What is the LMI IRRIGATION CATHETER (IGR) used for?

It is used for intra‑operative flushing of arterial or venous vessels following thrombectomy procedures. The catheter delivers fluid through its lumen to clear residual thrombus from the vessel during surgery.

How is the device supplied and is it sterile?

The device is supplied as a single‑use, sterile unit. It is intended for disposable use in the operating room and should not be resterilized or reused.

What materials and design features does it have?

It consists of a stainless‑steel wire‑reinforced silicone tube with a rounded leading nose, a female luer connector, strain relief, and four side ports. The reinforcement provides flexibility and kink resistance during vessel flushing.

Is this device reusable or single‑use?

It is strictly single‑use. The manufacturer specifies sterile, disposable use only; reusing or reprocessing the catheter could compromise sterility and structural integrity.

What regulatory pathway was used for clearance?

The device was cleared under the FDA 510(k) premarket notification pathway, specifically under K972623, with a substantial equivalence determination for cardiovascular embolectomy 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: K972623 FDA 510 (k) - LMI IRRIGATION CATHETER (IGR), Lucas Lmi Irrigation Catheter (igr) - allmed.wiki, LMI IRRIGATION CATHETER (IGR) (K972623) — FDA 510(k) | Innolitics, Lmi Irrigation Catheter (igr) 510 (k) FDA Premarket Notification ..., LMI IRRIGATION CATHETER (IGR) (K972623) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lucas Medical Inc
FDA Applicant
Lucas Medical, Inc.

Sources (1)

  • FDA 510(k) K972623 24 fields · synced Oct 6, 2026