# K991646: Agility Steerable Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Sep 23, 1999 after 133 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dasher®: named in the summary without a submission number
- (no number) TRANSEND™ Guidewire: named in the summary without a submission number
- (no number) INSTINCT™ Guidewire: named in the summary without a submission number
- (no number) ESSENCE™ Guidewire: named in the summary without a submission number

## Most influential descendants
- K100351: Neuroscout Steerable Guidewire (2010), 3 descendants of its own
- K121776: Agility Steerable Guidewire Neuroscout Steerable Gudiewire (2012), 1 descendant of its own
- K151825: Viradius Neurowire (2015), 0 descendants of its own
- K133625: Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN X 205CM & XL 350CM, Agility 16 Standard & (2014), 0 descendants of its own
- K023700: PVS 1600 Synchro 0.010 Neuro Guide Wire (2002), 0 descendants of its own

## Indications for use
The Cordis Endovascular AGILITY™ Steerable Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

Source page: https://510kreport.com/device/K991646
Methodology: https://510kreport.com/methodology