# K121077: Nhancer

- Pathway: 510(k) (Traditional)
- Applicant: Imds Operations B.V.
- Decided: Dec 21, 2012 after 256 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: 4 generations back to K935425 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033678: Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 and 518-038, Spectranetics Corp. (2004) Summary page 2.

## Indications for use
The IMDS NHancer™ Guide Wire Support Catheter with Hydrophilic Coating is a guidewire exchange and infusion device designed for use in the vascular system. The IMDS NHancer™ guidewire support catheter is intended to support a guidewire during access of vasculature and allows for exchange of guidewires and provides a conduit for the delivery of diagnostic contrast agents.

Source page: https://510kreport.com/device/K121077
Methodology: https://510kreport.com/methodology