Viking Optima Guiding Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K001435 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Guidant Corp. →

• What is the Viking Optima Guiding Catheter used for?

  The Viking Optima Guiding Catheter is designed for cardiovascular procedures, specifically to assist in the delivery and positioning of interventional devices like balloons or stents within coronary or peripheral arteries. Its structure provides mechanical support and stability to guidewires and catheters, reducing vessel trauma and improving procedural success during diagnostic and therapeutic angiography.

• Is the Viking Optima Guiding Catheter single-use or reusable?

  The Viking Optima Guiding Catheter is supplied as a single-use, sterile product. This design ensures patient safety and reduces the risk of cross-contamination, making it ideal for controlled clinical settings such as cardiac catheterization labs.

• What sizes and configurations are available for the Viking Optima Guiding Catheter?

  The Viking Optima Guiding Catheter is available in specific sizes and configurations tailored for both coronary and peripheral vascular applications. These variations allow clinicians to select the appropriate catheter for their procedural needs, ensuring optimal maneuverability and compatibility with different interventional devices.

• How should the Viking Optima Guiding Catheter be stored?

  The Viking Optima Guiding Catheter must be stored following standard sterile medical device protocols to maintain its integrity before use. This includes keeping it in a clean, dry environment, protected from physical damage, and adhering to manufacturer guidelines for shelf life and handling to ensure sterility and functionality.

• Is the Viking Optima Guiding Catheter MRI-compatible?

  There are no noted MRI compatibility restrictions for the Viking Optima Guiding Catheter. However, as with all medical devices, clinicians should verify compatibility with their specific MRI systems and protocols before use to avoid potential interference or safety risks.