# K963749: High Pressure Injection Lines

- Pathway: 510(k) (Traditional)
- Applicant: Maxxim Medical
- Decided: Dec 17, 1996 after 90 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911884 (1994). 1 ancestor in all.
7 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911884: Advance Pressure Monitor/High Pressure Lines, Advance Medical Designs, Inc. (1994) Summary page 1.

## Most influential descendants
- K023591: Ultra High Pressure Injector Lines (2003), 3 descendants of its own
- K071196: Disposable High Pressure Injection Lines with and Without Rotating Adapters (2007), 2 descendants of its own
- K152387: Fluent Inflation Device (2015), 1 descendant of its own
- K162272: Fluent inflation device (2016), 0 descendants of its own
- K140356: Summed High Pressure Line (2015), 0 descendants of its own

## Indications for use
Conduit tubing to deliver fluids from an electronic or manual injector; connector tubing to provide a sterile fluid pathway between two devices.

Source page: https://510kreport.com/device/K963749
Methodology: https://510kreport.com/methodology