Viking Optima Guiding Catheter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K012002 ↗

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 to guide other instruments during vascular procedures, facilitating the delivery of diagnostic or therapeutic devices within the vasculature.

• Is the Viking Optima Guiding Catheter sterile or non-sterile, and is it intended for single use or reuse?

  The device is supplied non-sterile and is intended for single use only, as stated in its specifications, to ensure patient safety and prevent cross-contamination during vascular procedures.

• What regulatory pathway was used for the Viking Optima Guiding Catheter, and what is its k-number?

  The Viking Optima Guiding Catheter received FDA 510(k) clearance under k-number K012002, demonstrating substantial equivalence to a predicate device under product code DQY.