📋 FDA Reference
Viking Optima Guiding Catheter
Guidant
Summary: The Viking Optima Guiding Catheter is a medical device used in interventional cardiology procedures to guide other instruments into the vascular system. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K012002 ↗
Decision Date ?
July 26, 2001
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Viking Optima Guiding Catheter received FDA clearance through the 510(k) pathway on July 26, 2001. It is manufactured by Guidant and classified as a Class 2 device.
What It Is
The Viking Optima Guiding Catheter is a specialized catheter designed to facilitate the placement of other interventional devices within the vascular system. It is typically used in procedures requiring precise navigation through blood vessels, such as angioplasty or stent placement. The catheter is engineered to provide optimal support and control during these procedures, enhancing the clinician's ability to reach target sites within the vasculature.
FDA-Cleared Indications
- Used to guide and support the placement of other interventional devices within the vascular system.
- Intended for percutaneous vascular procedures in which catheter-based devices are introduced and directed to a target vessel.
Clinical Applications
- Providing catheter support during percutaneous vascular interventions.
- Guiding interventional devices used during venous stent placement.
- Providing access and device support during catheter-based treatment of the iliac or central veins.
Practical Considerations
- The appropriate catheter size, shape and length depend on the access site, target vessel and devices being used.
- The catheter is compatible only with interventional devices and guidewires that meet the labeled size and compatibility requirements.
- It is advanced under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- Potential catheterization risks include bleeding, infection, vessel injury, dissection, thrombosis, embolization and contrast-related complications.
- MRI safety should be confirmed from the current device labeling and institutional protocol; do not assume that a catheter left in the body is MRI safe.
Procedures that use this device
Frequently Asked Questions
What is the Viking Optima Guiding Catheter used for?
It is used to guide other interventional devices into the vascular system during procedures like angioplasty or stent placement.
What specialties typically use this device?
Interventional cardiologists primarily use this device in cardiac catheterization labs.
What are the FDA-cleared indications?
The catheter is indicated for guiding devices through the vascular system, particularly in procedures involving venous stents.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.