# K152978: DeRoyal Angiography Kits

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Mar 25, 2016 after 168 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- 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 K913682 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933846: Angiography Syringe Kits, Angiodynamics, Div. E-Z-Em, Inc. (1994) Summary page 4.
- K913682: Merit Custom Kit, Merit Medical Systems, Inc. (1991) Summary page 4.

## Indications for use
DeRoyal Angiography Kits are intended for use by licensed physicians. The intended use of individual medical products assembled in these kits will not be changed from the manufacturer's original intended use. These kits are assembled of devices used during cardiac catheterization laboratory procedures such as cardiac catheterization, angiography, arteriogram, etc.

Source page: https://510kreport.com/device/K152978
Methodology: https://510kreport.com/methodology