← Back to catalogue

The Unballoon Non-Occlusive Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110891

by LeMaitre Vascular, Inc.

Identifiers

510(k) Number
K110891 FDA 510(k)
FDA Product Code
DQY FDA 510(k)
Models / Variants
The Unballoon Non-Occlusive Catheter FDA 510(k)
The Unballoon Non-Occlusive Modeling Catheter FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Unballoon Non-Occlusive Catheter is a medical device intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels. It allows for precise stent deployment without occluding blood flow, which is crucial in maintaining perfusion during vascular procedures.

This device is manufactured by LeMaitre Vascular, Inc. and is classified as a Class 2 device. It is designed for use in vascular procedures, particularly in the placement and modeling of venous stents, and is authorized under FDA 510K clearance with K number K110891.

Frequently asked questions

What is the primary purpose of the Unballoon Non-Occlusive Catheter?

The Unballoon Non-Occlusive Catheter is designed to assist in the modeling of self-expanding endoprostheses in large diameter vessels, allowing for precise stent deployment without occluding blood flow during vascular procedures.

How is the Unballoon Non-Occlusive Catheter supplied?

The device is supplied as a single-use catheter designed for vascular procedures, particularly in the placement and modeling of venous stents, with no information indicating multiple use or sterilization requirements.

What regulatory clearance does the Unballoon Non-Occlusive Catheter have?

The device has FDA 510K clearance with K number K110891, classified as a Class 2 device, and is authorized for use in vascular procedures under this regulatory pathway.

What sizes and models of the Unballoon Non-Occlusive Catheter are available?

The device data does not specify available sizes or models, only that it is designed for use in large diameter vessels for vascular procedures involving self-expanding endoprostheses.

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: The Unballoon Non-occlusive Catheter; the Unballoon Non-occlusive ..., Unballoon Non-Occlusion Modeling Catheter - Lemaitre Vascular | FDA ..., the unballoon non-occlusive catheter the unballoon non-occlusive ..., The Unballoon Non-occlusive Catheter; the Unballoon Non-occlusive ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
LeMaitre Vascular, Inc.

Sources (1)

  • FDA 510(k) K110891 24 fields · synced Oct 6, 2026