# K200324: NHancer Rx

- Pathway: 510(k) (Traditional)
- Applicant: Imds Operations B.V.
- Decided: Aug 6, 2020 after 178 days
- Product code: DQY (Catheter, Percutaneous)
- 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 K010579 (2001). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162467: Twin-Pass Torque, Vascular Solutions, Inc. (2017) Summary page 4.

## Most influential descendants
- K210431: ReCross (2021), 0 descendants of its own

## Indications for use
The NHancer Rx Dual Lumen Rapid Exchange catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.

Source page: https://510kreport.com/device/K200324
Methodology: https://510kreport.com/methodology