Instructions for Use Summary - VIKING Guiding Catheter
Indications, Contraindications, Warnings, Precautions, Adverse Events
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Indications
This Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced.
Contraindications
There are no known contraindications for this device.
Warnings
This device is distributed STERILE, NON-PYROGENIC and is intended for single-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.
Sideholes should not be placed in the shaft of the guiding catheter by the user. Puncturing the shaft of the guiding catheter with hospital instruments may lead to thrombogenesis or failure of shaft integrity.
When this catheter is in the body, observe manipulation while under high-quality fluoroscopy.
Precautions
Prior to use, examine the catheter to verify proper function and ensure that its size and shape are suitable to the specific procedure for which it is to be used.
Only physicians trained in procedures requiring percutaneous catheter introduction should use guiding catheters.
Appropriate anti-coagulation of the patient is indicated with the use of this device.
LT2922560
