# K132928: Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO Syringe

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc. / Bayer Medical Care, Inc.
- Decided: Jan 23, 2014 after 127 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903390 (1990). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K113133: Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion Arterion Syringe, Medrad, Inc. (2011) Summary page 1.
- K112086: Medrad Mark 7 Arterion  (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe, Medrad, Inc. (2011) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Sep 14, 2021 · Class II · Z-0199-2022: Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
- Aug 4, 2015 · Class II · Z-2775-2015: Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position.

## 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. The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies. The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

Source page: https://510kreport.com/device/K132928
Methodology: https://510kreport.com/methodology