# K012002: Viking Optima Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Jul 26, 2001 after 29 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001435 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001435: Viking Optima Guiding Catheter, Guidant Corp. (2000) Summary page 1.

## Indications for use
The guiding catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced.

Source page: https://510kreport.com/device/K012002
Methodology: https://510kreport.com/methodology