# K113133: Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion Arterion Syringe

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Dec 15, 2011 after 52 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: 2 generations back to K903390 (1990). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112086: Medrad Mark 7 Arterion  (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe, Medrad, Inc. (2011) Summary page 1.

## Most influential descendants
- K132928: Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO Syringe (2014), 2 descendants of its own
- K193028: MEDRAD Mark 7 Arterion Injection System (2019), 0 descendants of its own
- K173450: PRESS DUO elite, PRESS DUO elite AG (2018), 0 descendants of its own

## Indications for use
The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

Source page: https://510kreport.com/device/K113133
Methodology: https://510kreport.com/methodology