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Glider PTCA Balloon Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111544

by Trireme Medical, Inc.

Identifiers

510(k) Number
K111544 FDA 510(k)
FDA Product Code
LOX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5100 FDA 510(k)
Regulation Number
870.5100 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Glider PTCA Balloon Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, designed to dilate narrowed or obstructed coronary arteries. It employs a semi-compliant balloon with a skived tip and low-profile entry to facilitate precise navigation through complex vascular structures, including stent struts and bifurcations.

This device is supplied as a single-use, non-sterile catheter intended for interventional cardiology procedures. It is classified as a Class II medical device under FDA regulations (870.5100) and has received FDA 510K clearance as substantially equivalent. Sizes and reference codes are specified in the device’s registration data, ensuring compatibility with various coronary interventions. No MRI safety information is provided.

Frequently asked questions

What is the Glider PTCA Balloon Catheter specifically designed to treat and how does its design help in complex cases?

The Glider PTCA Balloon Catheter is designed to dilate narrowed or obstructed coronary arteries, aiding blood flow in patients with coronary artery disease. Its semi-compliant balloon, combined with a skived tip and low-profile entry, allows for precise navigation through challenging vascular structures, including stent struts and bifurcations, which are common in complex coronary interventions.

Is the Glider PTCA Balloon Catheter intended for reuse, or is it meant to be used only once per patient?

The Glider PTCA Balloon Catheter is explicitly supplied as a single-use device, meaning it is intended for one-time use per patient and should not be reused. This aligns with standard medical device practices to ensure patient safety and sterility.

What sizes and models are available for the Glider PTCA Balloon Catheter, and how do I determine compatibility for my procedure?

The Glider PTCA Balloon Catheter comes in multiple sizes and reference codes, as listed in the device’s registration data (e.g., FEI numbers like 3015002281, 3002095335, etc.). These variations ensure compatibility with different coronary artery diameters and procedural requirements. The manufacturer’s documentation or a clinical specialist can help select the appropriate size based on your patient’s anatomy and the specific intervention planned.

Is the Glider PTCA Balloon Catheter sterile when received, and if not, what precautions should be taken before use?

The Glider PTCA Balloon Catheter is non-sterile as supplied. Before use, it must be sterilized using appropriate medical-grade sterilization methods (e.g., ethylene oxide or gamma irradiation) in accordance with facility protocols. Always follow your institution’s sterile processing guidelines to ensure safety and efficacy.

What regulatory pathway was followed for FDA clearance of the Glider PTCA Balloon Catheter, and how does this affect its use?

The Glider PTCA Balloon Catheter received FDA 510K clearance under the Traditional pathway, determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with FDA standards for safety and effectiveness as a Class II medical device (product code LOX) under regulation 870.5100. Clinicians may rely on this clearance to ensure the device meets regulatory requirements for coronary angioplasty procedures.

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: Glider™ PTCA Balloon Catheter | LA | Teleflex, PTA catheter / balloon GliderfleX® TriReme Medical, TriReme Medical,PTCA catheter / balloon TriReme Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Trireme Medical, Inc.

Sources (1)

  • FDA 510(k) K111544 24 fields · synced Sep 19, 2026