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LP Delivery System
Device Description
The AMPLATZER TorqVue LP low-profile delivery system consists of a delivery catheter, loader, and hemostasis valve. Optional
components of the AMPLATZER TorqVue LP delivery system are a delivery wire and plastic vise. The delivery system is
designed to provide a pathway through which devices are introduced into the peripheral vasculature. The body of the delivery
catheter is radiopaque for visibility under fluoroscopy.
E
Figure 1. AMPLATZER TorqVue LP Delivery System Components
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 LP delivery system is intended to provide a pathway through which devices are introduced into the
peripheral vasculature.
Contraindications
None known.
© 2007, 2008 AGA Medical Corporation
AMPLATZER and TorqVue are trademarks of AGA Medical Corporation.
AGA Medical products and technologies for which patents are granted and/or pending in the USA
and/or other countries are listed at www.amplatzer.com/patents.html
Not in any way connected with medical gas or equipment sold under the "AGA" brand by AGA AB
or its successors.
Instructions for Use
A
D
B
C
1
600267-002
04-2008 US
Manufacturing Facility:
5050 Nathan Lane North
Plymouth, MN 55442-5798 USA
+1.888.546.4407 Toll Free
+1.763.513.9227 Phone
+1.763.513.9226 Fax
www.amplatzer.com
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Summary of Contents for AGA Medical Amplatzer TorqVue LP
- Page 1 The AMPLATZER TorqVue LP low-profile delivery system consists of a delivery catheter, loader, and hemostasis valve. Optional components of the AMPLATZER TorqVue LP delivery system are a delivery wire and plastic vise. The delivery system is designed to provide a pathway through which devices are introduced into the peripheral vasculature. The body of the delivery catheter is radiopaque for visibility under fluoroscopy.
- Page 2 Warnings • The delivery system is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. • Do not use the delivery system if the sterile pouch is open or damaged. • Use the hemostasis valve to impede the backflow of blood during the implant procedure. •...
- Page 3 AGA Medical Corporation's obligation under this warranty is limited to replacing or repairing at its option, at its factory, this product if returned within the warranty period to AGA Medical Corporation and after confirmed to be defective by the manufacturer.
- Page 4 Symbol Definitions The following symbols may appear on the device packaging: Symbol Definition Manufacturer EU authorized representative Product serial number Product lot number Use By date Do not reuse Sterilized using ethylene oxide Consult operating instructions Caution, consult accompanying documents Keep dry Federal law (USA) restricts this device to sale by or on the order of a physician (or...
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