# K933846: Angiography Syringe Kits

- Pathway: 510(k) (Traditional)
- Applicant: Angiodynamics, Div. E-Z-Em, Inc.
- Decided: Dec 13, 1994 after 494 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K152978: DeRoyal Angiography Kits (2016), 0 descendants of its own

## Recalls of this device
- Nov 12, 2018 · Class II · Z-0654-2019: Insufficient seal on the sterile barrier of the device, compromising the sterility of the device

Source page: https://510kreport.com/device/K933846
Methodology: https://510kreport.com/methodology