# K112565: Novaport One Vascular Access Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Novalung GmbH
- Decided: Dec 6, 2011 after 95 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- 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 K840001 (1984). 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)
- K052524: Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit, Medtronic Perfusion Systems (2005) Summary page 1.
- K024069: One Piece Pediatric Arterial Cannula, Model: 77006, 77106, Medtronic Vascular (2003) Summary page 1.

## Indications for use
The NovaPort® One Vascular Access cannula with its associated Introducer Kit is a percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to < 6 hours.

Source page: https://510kreport.com/device/K112565
Methodology: https://510kreport.com/methodology