# K903390: Medrad Mark V-Plus Injector

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Sep 26, 1990 after 61 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.
6 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K112086: Medrad Mark 7 Arterion  (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe (2011), 4 descendants of its own
- 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.

Source page: https://510kreport.com/device/K903390
Methodology: https://510kreport.com/methodology