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Amplatzer™ Trevisio™
Intravascular Delivery System
Device Description
The Amplatzer™ Trevisio™ Intravascular Delivery System is designed to deliver Amplatzer™ devices. The device and delivery
system are shipped separately. The body of the sheath is radiopaque for visibility under fluoroscopy.
Figure 1. Amplatzer™ Trevisio™ Intravascular Delivery System Components
A. Loader – Introduces an Amplatzer
B. Hemostasis valve with extension tube and stopcock – Allows flushing of the delivery system and controls blood backflow
C. Sheath – Provides a pathway through which an Amplatzer
D. Dilator – Eases penetration of tissue and minimizes vessel trauma
E. Delivery cable – Attaches to the device to control its movement through the sheath
F. Plastic vise – Attaches to the delivery cable and serves as a handle for disconnecting (unscrewing) the delivery cable from a
device
Indications and Usage
The Amplatzer™ Trevisio™ Intravascular Delivery System is intended to provide a pathway through which devices are
introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
Contraindications
None known.
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third party trademark, which is property of its respective owner.
Pat. http://www.abbott.com/patents
© 2019 Abbott. All Rights Reserved.
Instructions for Use
™
device into the sheath
™
device is delivered
1
ARTEN600052467 B
2019-02
Manufacturing facility:
Abbott Medical
5050 Nathan Lane North
Plymouth, MN
55442 USA
+1 855 478 5833
+1 651 756 5833
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Related Manuals for Abbott Amplatzer Trevisio 9-ATV06F45
Summary of Contents for Abbott Amplatzer Trevisio 9-ATV06F45
- Page 1 Contraindications None known. ARTEN600052467 B 2019-02 ™ Indicates a trademark of the Abbott group of companies. Manufacturing facility: ‡ Indicates a third party trademark, which is property of its respective owner. Abbott Medical Pat. http://www.abbott.com/patents 5050 Nathan Lane North ©...
- Page 2 Warnings • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient. • Do not use this device if the sterile package is open or damaged. •...
- Page 3 Table 2. Delivery System Dimensions Delivery system Inner diameter of Outer diameter of Model Number/Delivery (sheath) size sheath sheath System Size (mm) 6 Fr 2.11 mm (0.08 in) 2.79 mm (0.11 in) 9-ATV06F45/60 7 Fr 2.44 mm (0.10 in) 3.18 mm (0.13 in) 9-ATV07F45/60 7 Fr 2.44 mm (0.10 in)
- Page 4 Warranty Abbott Medical warrants to buyer that, for a period equal to the validated shelf life of the product, this product shall meet the product specifications established by the manufacturer when used in accordance with the manufacturer's instructions for use and shall be free from defects in materials and workmanship.
- Page 5 Consult instructions for use Follow instructions for use on this website Keep dry Do not use if package is damaged Not made with natural rubber latex Inner diameter Outer diameter Length Usable length Recommended delivery sheath/catheter dimensions Caution: Federal law restricts this device to sale by or on the order of a physician. Quantity Date of manufacture Intravascular Delivery System...