# K200439: Velano ExT Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Velano Vascular
- Decided: Feb 23, 2021 after 365 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: 9 generations back to K942988 (1995). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182897: Velano Vascular Q2 Extension Set, Velano Vascular (2019) Summary page 4.

## Most influential descendants
- K251257: nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] (2025), 0 descendants of its own
- K221518: NP Medical nCompass Extension Set with Stabilizing Base (2022), 0 descendants of its own

## Indications for use
The Velano ExT™ Extension Set with needle-free connector is for single use only. Each port of the Velano ExT™ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The pressure rated port of the Velano ExT™ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second.

Source page: https://510kreport.com/device/K200439
Methodology: https://510kreport.com/methodology