# K103377: Charter Guidewire Model 45-281, 45-282, 45-283

- Pathway: 510(k) (Special)
- Applicant: Brivant, Ltd.
- Decided: May 18, 2011 after 182 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: 7 generations back to K970376 (1997). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060551: Brivant Guidewire, Brivant Limited (2006) Summary page 1.
- K083094: Streamer Polymer Guidewire, Brivant, Ltd. (2009) Summary page 1.
- K073082: CPS Courier Guidewire, Brivant, Ltd. (2008) Summary page 1.

## Most influential descendants
- K141831: Hydraview Guidewire (2014), 0 descendants of its own
- K122856: Charter Guidewire (2012), 0 descendants of its own

## Indications for use
Charter Guidewires are intended for use in the coronary and peripheral vasculature. Contraindications: 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/K103377
Methodology: https://510kreport.com/methodology