# K161287: DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Aug 19, 2016 after 102 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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: 4 generations back to K921310 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082736: Radifocus Optitorque Angiographic Catheter, Terumo Medical Corp. (2008) Summary page 4.

## Recalls of this device
- Aug 16, 2018 · Class III · Z-3253-2018: Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correc
- Mar 13, 2018 · Class II · Z-1479-2018: The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, th

## Indications for use
The diagnostic catheter is indicated for cardiac and vascular procedures. It is designed to deliver radiopaque media, guidewires, and therapeutic agents to selected sites in the vascular system. The different configurations of the diagnostic catheter are designed to be used in arteries from access sites such as the radial, brachial, and femoral arteries.

Source page: https://510kreport.com/device/K161287
Methodology: https://510kreport.com/methodology