# K980417: Medrad Disposable Mri Kit W/Check Valve Modelsqk 65V, Medrad Mri Integral T with Check Valve Model Sit 96V

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: May 4, 1998 after 90 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943189 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943189: Medrad Qwik-Fix Mri Disposable Kit, Medrad, Inc. (1995) Summary page 1.

## Indications for use
ThE Medrad Disposable MRI Kit with Check Valve is indicated for use in an MRI environment. The components of the kit are used to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates.

Source page: https://510kreport.com/device/K980417
Methodology: https://510kreport.com/methodology