# K150860: Nitroglycerin Sets with DUO-VENT Spike

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Apr 16, 2015 after 15 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K811078 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832284: Solution Admin. Set 2C9096 W/10 PVC, Travenol Laboratories, S.A. (1983) Summary page 5.
- K142011: Solution Set/Extension Set, Baxter Healthcare Corporation (2014) Summary page 5.

## Indications for use
For the administration of Nitroglycerin solution from a container into the patient’s vascular system through a vascular access device.

Source page: https://510kreport.com/device/K150860
Methodology: https://510kreport.com/methodology