# K122856: Charter Guidewire

- Pathway: 510(k) (Special)
- Applicant: Brivant, Ltd.
- Decided: Oct 17, 2012 after 29 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K970376 (1997). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103377: Charter Guidewire Model 45-281, 45-282, 45-283, Brivant, Ltd. (2011) Summary page 1.

## Indications for use
Charter"' Guidewires are intended for use in the coronary and peripheral vasculature. Contraindlications: The Charter Guidewire is not intended.for use in the cerebral vasculature. Patients judged not acceptable for percutaneous intervention (PCI).

Source page: https://510kreport.com/device/K122856
Methodology: https://510kreport.com/methodology