Приспособления для эндоваскулярных операций: стент cистема коронарная Xience Pro, элюирующая Everolimus:

Šalis: Baltarusija

kalba: rusų

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

Prieinama:

Abbott Vascular, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

Klasė:

изделия медицинского назначения

Pagaminta:

Abbott Vascular

Leidimo data:

2020-09-03

Prekės savybės

БЪЛГАРСКИ / BULGARIAN
ROMÂNĂ / ROMANIAN
PPL2122126-02 (2019-03-26)
English
MULTI-LINK MINI VISION
Coronary Stent Systems
1.0
DEVICE DESCRIPTION
The MULTI-LINK MINI VISION RX Coronary Stent System and the MULTI-LINK
MINI VISION OTW Coronary Stent System (MULTI-LINK MINI VISION
Coronary Stent and RX or OTW Delivery System) include:
•
A pre-mounted L-605 cobalt chromium alloy (CoCr) (major elements
include cobalt, chromium, tungsten, nickel) stent.
•
Two radiopaque markers, located underneath the balloon, which
fluoroscopically mark the working length of the balloon and the
expanded
stent length.
•
Two proximal Delivery System shaft markers (95 cm and 105 cm from the
distal tip) that indicate the relative position of the Delivery System
to the end of a brachial or femoral guiding catheter. Working catheter
length is 143 cm.
•
For the MULTI-LINK MINI VISION RX Coronary Stent System only, a shaft
color change denotes the guide wire exit notch.
Table 1: _in vitro_ Device Specifications
Stent
Diameter
(mm)
Stent Length
(mm)
*Minimum Guiding Catheter
Compatibility ID
5F (0.056” / 1.42 mm)
**_in vitro_ Stent
Nominal
Pressure
(atm)
Rated Burst
Pressure -RBP
(atm)
Stent Free %
Area
2.0
8, 12, 15, 18, 23, 28
5F
8
16
81
2.25
8, 12, 15, 18, 23, 28
5F
9
16
83
2.5
8, 12, 15, 18, 23, 28
5F
9
16
85
*See Individual manufacturer specifications for (F) equivalent.
**Assure full deployment of the stent (See Clinician Use Information
– Deployment Procedure). Deployment pressures should be based on
lesion characteristics.
2.0
HOW SUPPLIED
Sterile. This device is sterilized with electron beam radiation.
Non-pyrogenic. Do not use if the package is open or damaged.
This single use device cannot be reused on another patient, as it is
not designed to perform as intended after the first usage. Changes in
mechanical,
physical, and / or chemical characteristics introduced under
conditions of repeated use, cleaning, and / or resterilization may
compromise the integrity
of the design and / or materials, leading to contamina