# K211110: Agile Devices Angler Steerable, Deflectable Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Agile Devices, Inc.
- Decided: Jan 7, 2022 after 268 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K960806 (1996). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200582: Bendit2.7 Steerable Microcatheter, Bend IT Technologies, Ltd. (2020) Summary page 4.
- K161921: SwiftNINJA Microcatheter, Merit Medical Systems, Inc. (2016) Summary page 4.

## Indications for use
The Agile Devices Angler™ Steerable, Deflectable Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled infusion of diagnostic agents and delivery of embolic or therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.

Source page: https://510kreport.com/device/K211110
Methodology: https://510kreport.com/methodology