Изделия для рентгенэндоваскулярной хирургии: проводник Traxcess:

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

MicroVention, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

MicroVention

Дата Авторизация:

2023-08-01

Характеристики продукта

English
Headway
®
Microcatheter with Hydrophilic Coating
Instructions for Use
DEVICE DESCRIPTION
The Headway Microcatheter is a single lumen catheter designed to be
introduced over a steerable guidewire to access small, tortuous
vasculature. The
semi-rigid proximal section transitions to a flexible distal tip to
facilitate advancement through vessels. Dual radiopaque markers at the
distal end facilitate
fluoroscopic visualization. The outer surface of the Microcatheter is
coated with a hydrophilic polymer to increase lubricity. A luer
fitting on the Microcatheter
hub is used for the attachment of accessories.
CONTENTS
One Headway Microcatheter with shaping mandrel and introducer sheath.
INDICATIONS FOR USE
The Headway Microcatheter is intended for general intravascular use,
including the peripheral, coronary and neuro vasculature for the
infusion of diagnostic
agents, such as contrast media, and therapeutic agents, such as
occlusion coils.
CONTRAINDICATIONS
There are no known contraindications.
CAUTION
RX-Only: Federal law (USA) restricts this device to sale by or on the
order of a physician.
WARNINGS
The Microcatheter should only be used by physicians who are familiar
with angiographic and interventional procedures. It is important to
follow the instructions
for use prior to using this product.
The Microcatheter is provided sterile and non-pyrogenic unless the
unit package is opened or damaged. Do not use if the packaging is
breached or damaged.
The Microcatheter is intended for single use only. Do not resterilize
and/or reuse the device. After use, dispose device in accordance with
hospital and/or local
government policy.
Inspect the Microcatheter prior to use for any irregularities or
damage and discard if any inconsistencies are observed.
The Microcatheter should be advanced or manipulated under fluoroscopic
guidance. Do not advance or withdraw the device when excessive
resistance is met
until the cause of resistance is determined.
Infusion pressure should not exceed 300 psi to avoid potential rupture
of the