# K142673: Bio-Medicus Adult Cannulae and Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Nov 18, 2014 after 60 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 K003288 (2001). 3 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884129: Bio-Medicus Percutaneous Cannula & Introducer Set, Bio Medicus, Inc. (1988) Summary page 4.
- K081820: Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR, Avalon Laboratories, LLC (2008) Summary page 4.

## Most influential descendants
- K180453: Bio-Medicus Adult Cannulae and Introducer (2018), 6 descendants of its own
- K203067: Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F (2021), 2 descendants of its own
- K201100: Bio-Medicus Life Support Catheter and Introducer (2021), 2 descendants of its own
- K221353: Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS (2022), 1 descendant of its own
- K153598: Medtronic Bio-Medicus Adult Cannula Kit (2016), 1 descendant of its own

## Indications for use
These devices are to be used by a trained physician only. Cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-MedicusTM cannula (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula. This product is intended for use up to 6 hours.

Source page: https://510kreport.com/device/K142673
Methodology: https://510kreport.com/methodology