Question 1

What types of medical devices does Trireme Medical, LLC manufacture?

Accepted Answer

Trireme Medical, LLC specialises in angioplasty balloon catheters, specifically peripheral and coronary dilation devices. These include basic peripheral angioplasty balloon catheters and coronary angioplasty balloon catheters, such as the Chocolate PTA Balloon Catheter and Gliderflex PTA Balloon Catheter. These devices are designed for vascular interventions to widen narrowed or blocked arteries.

Question 2

Where is Trireme Medical, LLC based?

Accepted Answer

Trireme Medical, LLC is based in the United States. The company’s location is relevant for regulatory oversight, as its devices are authorised under US medical device regulations.

Question 3

Which regulatory registries list Trireme Medical, LLC’s devices?

Accepted Answer

Trireme Medical, LLC’s devices are listed in the FDA’s 510(k), PMA, and UDI registries. These registries track devices authorised under the US Food and Drug Administration’s classification system, ensuring compliance with safety and performance standards for medical devices.

Question 4

How are Trireme Medical, LLC’s devices classified under FDA regulations?

Accepted Answer

Trireme Medical, LLC’s devices are classified as either Class II or Class III under FDA regulations. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Class III devices are higher risk and require pre-market approval (PMA) due to insufficient data to assure safety and performance through less stringent means.

Device	Model / Reference	Registries	Class	Status
Chocolate Pta Balloon Catheter (over The Wire) 0.014 Guide Wire Chocolate Pta Balloon Catheter (over The Wire) 0.018' G	K121402	FDA 510(k)	Class II	Active
Glider Pta Balloon Catheter	K094019	FDA 510(k)	Class II	Active
Chocolate Pta Balloon Catheter (over The Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (over The Wire) 0.018	K130414	FDA 510(k)	Class II	Active
Glider Pta Balloon Catheter	K101062	FDA 510(k)	Class II	Active
Glider Ptca Balloon Catheter	K121681	FDA 510(k)	Class II	Active
Chocolate Ptca Bolloon Catheter	K133633	FDA 510(k)	Class II	Active
Chocolate Pta Balloon Catheter (over The Wire) Guide Wire (0.014 And 0.018)	K111738	FDA 510(k)	Class II	Active
Chocolate Pta Ballon Catheter (over The Wire) Guide Wire (0.014)	K120677	FDA 510(k)	Class II	Active
Glider Ptca Balloon Catheter	K111544	FDA 510(k)	Class II	Active
Gliderxtreme Pta Balloon Catheter (cb) (over The Wire) 0.014 / 0.018 Guide Wire	K103534	FDA 510(k)	Class II	Active
Chocolate XD PTCA Balloon Catheter	K153682	FDA 510(k)	Class II	Active
Chocolate Pta Balloon Catheter (over The Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (over The Wire) 0.18 G	K122070	FDA 510(k)	Class II	Active
Gliderxtreme Pta Ballon Catheter (over The Wire) 0.018 Guide Wire 6100-Xxxxx, 6100cb-Xxxx	K112281	FDA 510(k)	Class II	Active
Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)	P210039	FDA PMA	Class III	Active

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