TABLE OF CONTENTS
WARNING ............................................................................................................................3
DEVICE DESCRIPTION .......................................................................................................3
Figure 1. Comet™ Pressure Guidewire ......................................................................3
USER INFORMATION..........................................................................................................3
Contents ..........................................................................................................................3
INTENDED USE....................................................................................................................3
INDICATIONS FOR USE ......................................................................................................3
CONTRAINDICATIONS .......................................................................................................3
WARNINGS ..........................................................................................................................3
PRECAUTIONS.....................................................................................................................4
ADVERSE EVENTS ..............................................................................................................4
HOW SUPPLIED...................................................................................................................4
Handling and Storage ...................................................................................................4
Preparation .....................................................................................................................5
Diagnostic Procedure ...................................................................................................5
Intervention .....................................................................................................................5
Technical Specifications ..............................................................................................6
WARRANTY .........................................................................................................................6
Black (K) ∆E ≤5.0
2
C