# K193028: MEDRAD Mark 7 Arterion Injection System

- Pathway: 510(k) (Special)
- Applicant: Bayer Medical Care, Inc.
- Decided: Dec 5, 2019 after 36 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: 4 generations back to K903390 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132928: Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO Syringe, Medrad, Inc. / Bayer Medical Care, Inc. (2014) Summary page 4.

## Indications for use
MEDRAD® Mark 7 Arterion Injection System The MEDRAD® Mark 7 Arterion Injection System is indicated to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies. Imaging System Interface (ISI) The ISI option is indicated for the specific purpose of allowing a MEDRAD® Mark 7 Arterion Injection System to interface with an angiography imaging system.

Source page: https://510kreport.com/device/K193028
Methodology: https://510kreport.com/methodology