# K201076: Anchor Dual Lumen Guidewire Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Aqure Medical, Inc.
- Decided: Aug 6, 2020 after 106 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K010954 (2001). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140080: Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB, MPC & XB, Codman & Shurtleff, Inc. (2014) Summary page 5.
- K151396: MIVI Mi-AXUS Guide Catheter, Mivi Neuroscience, Inc. (2015) Summary page 5.

## Indications for use
The Anchor Dual Lumen Guidewire Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional devices.

Source page: https://510kreport.com/device/K201076
Methodology: https://510kreport.com/methodology