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AMPLATZER
TorqVue
™
Device Description
The AMPLATZER
TorqVue
™
Optional components of the AMPLATZER
system is designed to provide a pathway through which devices are introduced into the chambers and coronary vasculature of
the heart or into the peripheral vasculature. The body of the delivery catheter is radiopaque for visibility under fluoroscopy.
Note: Not made with natural rubber latex.
E
Figure 1. AMPLATZER
TorqVue
™
A. Loader – Introduces a device into the delivery catheter.
B. Hemostasis valve with extension tube and stopcock – Allows flushing of the delivery system and controls back-bleeding.
C. Delivery catheter – Provides a pathway through which a device is delivered.
D. Delivery wire (optional) – Attaches to a device for controlling its movement through the delivery catheter.
E. Plastic vise (optional) – Attaches to the delivery wire, serving as a "handle" for detaching (unscrewing) the delivery wire from a
device.
Indications for Use
The AMPLATZER
TorqVue
™
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
© 2018 Abbott. All Rights Reserved.
™
LP Delivery System
Instructions for Use
LP low-profile delivery system consists of a delivery catheter, loader, and hemostasis valve.
™
TorqVue
LP delivery system are a delivery wire and plastic vise. The delivery
™
™
A
D
LP Delivery System components
™
LP delivery system is intended to provide a pathway through which devices are introduced within
™
B
C
1
ARTEN600038215A
2018-09
Manufacturing facility:
Abbott Medical
5050 Nathan Lane North
Plymouth, MN
55442 USA
+1 855 478 5833
+1 651 756 5833
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Summary of Contents for Abbott AMPLATZER TorqVue LP
- Page 1 Contraindications None known. ARTEN600038215A 2018-09 ™ 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 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 4 Symbol Definitions The following symbols may appear on the device packaging: Symbol Definition Caution, consult accompanying documents Not made with natural rubber latex Manufacturer Contains phthalate EU authorized representative Reference number Product serial number Batch code Unique Device Identification Use by date (Use on or before the last day of the expiration month noted on the product packaging.) Do not reuse Sterilized using ethylene oxide...
- Page 5 Hydrophilic coating Recommended delivery sheath/catheter dimensions Date of manufacture Federal law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Quantity Delivery System...
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