# K112086: Medrad Mark 7 Arterion  (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Oct 14, 2011 after 85 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
Longest line of descent: 1 generation back to K903390 (1990). 2 ancestors in all.
4 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)
- K903390: Medrad Mark V-Plus Injector, Medrad, Inc. (1990) Summary page 1.
- K050456: Medrad Avanta Fluid Management Injection System, Medrad, Inc. (2005) Summary page 1.
- (no number) MEDRAD Mark V Provis Injection System: named in the summary without a submission number

## Most influential descendants
- K113133: Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion Arterion Syringe (2011), 3 descendants of its own
- 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

## Recalls of this device
- Dec 14, 2018 · Class II · Z-0745-2019: If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

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

Source page: https://510kreport.com/device/K112086
Methodology: https://510kreport.com/methodology