# K133625: Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN X 205CM & XL 350CM, Agility 16 Standard &

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Feb 24, 2014 after 90 days
- Product code: MOF (Guide, Wire, Catheter, Neurovasculature)
- 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: 3 generations back to K991646 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121776: Agility Steerable Guidewire Neuroscout Steerable Gudiewire, Codman & Shurtleff, Inc. (2012) Summary page 2.

## Indications for use
The AGILITY® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the nero, and peripheral vasculature. The NEUROSCOUT®1 Steerable Guidewires are intended for selective placement of niicrocalhcters and other devices in the neuro and peripheral vasculature.

Source page: https://510kreport.com/device/K133625
Methodology: https://510kreport.com/methodology