Question 1

What types of medical devices does Lucas Medical Inc manufacture?

Accepted Answer

Lucas Medical Inc specialises in devices used in vascular and biliary procedures. Their most common products include thrombectomy balloon catheters, which help remove blood clots from arteries, and carotid artery shunts, which maintain blood flow during surgeries like carotid endarterectomy. They also produce intravascular occluding balloon catheters for image-guided interventions, biliary drains for managing bile flow, and surgical irrigation-aspiration systems for cleaning and evacuating fluids during procedures.

Question 2

Where is Lucas Medical Inc based, and where are their devices authorised?

Accepted Answer

Lucas Medical Inc is based in the United States. Their devices are authorised for use in the U.S., where they are regulated under the FDA’s classification system. The company’s products are registered in the U.S. regulatory database, including listings in the FDA’s 510(k) premarket notification and Unique Device Identification (UDI) systems.

Question 3

Which regulatory registries list Lucas Medical Inc’s devices?

Accepted Answer

Lucas Medical Inc’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have undergone the necessary authorisation processes, such as 510(k) clearance, to ensure compliance with U.S. medical device regulations.

Question 4

How are Lucas Medical Inc’s devices classified by the FDA?

Accepted Answer

All of Lucas Medical Inc’s devices fall under FDA Class II classification. This classification applies to devices that generally present a moderate risk to users and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Class II devices typically require premarket notifications (510(k)s) to demonstrate substantial equivalence to legally marketed devices.

Question 5

Why do Lucas Medical Inc’s devices appear in the FDA’s UDI system?

Accepted Answer

The FDA’s Unique Device Identification (UDI) system assigns a unique identifier to medical devices to improve tracking, monitoring, and recall management. Lucas Medical Inc’s devices are included in this system because they are authorised for use in the U.S., and the UDI helps ensure transparency in the supply chain, aiding healthcare providers, regulators, and manufacturers in identifying and managing devices throughout their lifecycle.

Device	Model / Reference	Registries	Class	Status
Lmi Arterial Embolectomy Catheter	4FEMB100	FDA UDI	Class II	Active
Lmi Bilumen Irrigation Arterial Embolectomy Catheter	NL12IRR30D	FDA UDI	Class II	Active
Lmi Occlusion Catheter	4FOCC40	FDA UDI	Class II	Active
Lmi Carotid Endarterectomy Shunt Catheter	10FCESB30	FDA UDI	Class II	Active
Carotid Endarterectomy Shunt	10FCES15	FDA UDI	Class II	Active
Lmi Arterial Embolectomy Catheter	NL3EMB80T	FDA UDI	Class II	Active
Lmi Occlusion Catheter	5FOCC23	FDA UDI	Class II	Active
Lmi Occlusion Catheter	5FOCC40	FDA UDI	Class II	Active
Lmi Arterial Embolectomy Catheter	NL3FEMB40	FDA UDI	Class II	Active
Lmi Carotid Shunt With Safety Balloon Catheter	8FCBS400-40-1	FDA UDI	Class II	Active
Lmi Carotid Shunt With Safety Balloon Catheter	9FCBS400-40-2	FDA UDI	Class II	Active
Lmi Bilumen Irrigation (proximal) Arterial Embolectomy Catheter	7FIRR080P	FDA UDI	Class II	Active
Lmi Bilumen Irrigation (distal) Arterial Embolectomy Catheter	4FIRR080D	FDA UDI	Class II	Active
Lmi Carotid Shunt With Safety Balloon Catheter	10FCBS400-40-1	FDA UDI	Class II	Active
Lmi Bilumen Irrigation (distal) Arterial Embolectomy Catheter	6FIRR080D	FDA UDI	Class II	Active
Lmi Carotid Shunt With Safety Balloon Catheter	9FCBS100-10-1	FDA UDI	Class II	Active
Lmi Carotid Shunt With Safety Balloon Catheter	8FCBS100-10-1	FDA UDI	Class II	Active
Lmi Carotid Shunt With Safety Balloon Catheter	10FCBS100-10-2	FDA UDI	Class II	Active
Lmi Bilumen Irrigation Arterial Embolectomy Cahteter	K955499	FDA 510(k)	Class II	Active
Lmi Arterial Embolectomy Catheter	K954760	FDA 510(k)	Class II	Active
Lmi Carotid Endarterectomy Shunt Catheter, Model #'s Ces, Cesr, Cesb, Cesrb, Cest, Cestr, Cestb, Cestrb, Ces-Sb, Cesr-Sb	K983802	FDA 510(k)	Class II	Active
Lmi Occlusion Catheter	K955125	FDA 510(k)FDA UDI	Class II	Active
Lmi Irrigation Catheter (igr)	K972623	FDA 510(k)	Class II	Active
Lmi Thrombectomy Catheter	K970657	FDA 510(k)	Class II	Active
Lmi Biliary Catheter	K955126	FDA 510(k)	Class II	Active

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