# K260559: NHanceIT

- Pathway: 510(k) (Traditional)
- Applicant: IMDS Operation B.V.
- Decided: Aug 14, 2026 after 176 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: 10 generations back to K001992 (2000). 19 ancestors in all.
No later device cites it as a predicate yet.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191560: Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter, Vascular Solutions, LLC (2019) Summary page 5.

## Indications for use
The IMDS NHanceIT Guide Wire Support Catheter with hydrophilic coating is a guidewire exchange and infusion device designed for use in the coronary and/or peripheral vasculature. The catheter is intended to support a guidewire during access of coronary and/or peripheral vasculature and allows for exchange of guidewires and provide 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/K260559
Methodology: https://510kreport.com/methodology