# K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Bio-Medicus, Inc.
- Decided: Mar 26, 1993 after 193 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
No predicates in its family tree.
63 later devices descend from it; 10 cite it directly.
2 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012512: Setpoint Endovascular Temperature Management System (2002), 27 descendants of its own
- K022366: Celsius Control System (2003), 16 descendants of its own
- K030421: Alsius Coolgard 3000 & Alsius Catheter System (2003), 15 descendants of its own
- K031827: Ultraflex Venous Cannula, Model 970XX and CB970XX (2003), 15 descendants of its own
- K052570: Tandemheart Transseptal Cannula Set-EF, Model 5140-6221 (2006), 9 descendants of its own

## Recalls of this device
- May 9, 2008 · Not classified · Z-1928-2008: Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin.

Source page: https://510kreport.com/device/K924642
Methodology: https://510kreport.com/methodology