Instructions for Use - Veripath Peripheral Guiding Catheter (U.S. & Canada)
Indications, Contraindications, Warnings, Precautions, Adverse Events
Caution:
Federal (USA) law restricts this device to sale by or on the order of a
physician.
Intended Use
The peripheral guiding catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced into the peripheral vasculature. The inner catheter is intended to provide support during the introduction and withdrawal of a guiding catheter.
Contraindications
There are no known contraindications for this device.
Warnings
This device is distributed STERILE, NON-PYROGENIC and is intended for one time use only. Do NOT resterilize and / or reuse it, as this can potentially result in compromised device performance and risk of inappropriate sterilization and cross contamination.
When this guiding catheter (and inner catheter, if used) is in the body, it should be manipulated while under high-quality fluoroscopic observation.
The user should not place sideholes in the shaft of the guiding catheter. Puncturing the shaft of the guiding catheter with hospital instruments may lead to thrombogenesis or failure of shaft integrity.
Precautions
Prior to use, the device should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.
Guiding catheters should be used only by physicians trained in procedures requiring percutaneous catheter introduction.
Appropriate anticoagulation of the patient is indicated with the use of this device.
LT2922560
