# K232388: High Pressure Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Dizegens Medical Science Co.,Ltd
- Decided: Nov 21, 2023 after 104 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K170014: High Pressure Tubing. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6.

## Indications for use
High Pressure Tubing is indicated for use in PTCA surgery to connect the angiographic catheter and the angiographic syringe to deliver contrast media.

Source page: https://510kreport.com/device/K232388
Methodology: https://510kreport.com/methodology