# K181351: Double Flexible Tipped Wire Guides

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Jun 14, 2018 after 23 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K770977 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171912: Double Flexible Tip Wire Guides, Cook Incorporated (2018) Summary page 4.

## Recalls of this device
- Aug 16, 2022 · Class II · Z-1831-2022: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

## Indications for use
The Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K181351
Methodology: https://510kreport.com/methodology