# K143083: Bio-Medicus Pediatric Cannula and Introducers

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Mar 25, 2015 after 149 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K840001 (1984). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872033: Bio-Medicus Cannula-Tubing, Bio Medicus, Inc. (1987) Summary page 4.
- K024069: One Piece Pediatric Arterial Cannula, Model: 77006, 77106, Medtronic Vascular (2003) Summary page 4.

## Most influential descendants
- K201100: Bio-Medicus Life Support Catheter and Introducer (2021), 2 descendants of its own
- K251831: Bio-Medicus Life Support Catheter and Introducer (2026), 0 descendants of its own
- K240534: Bio-Medicus Life Support Catheter and Introducer (2024), 0 descendants of its own

## Recalls of this device
- Sep 21, 2017 · Class II · Z-0640-2018: Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.

## 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. These products are intended for use up to 6 hours.

Source page: https://510kreport.com/device/K143083
Methodology: https://510kreport.com/methodology