# K884129: Bio-Medicus Percutaneous Cannula & Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Bio Medicus, Inc.
- Decided: Dec 21, 1988 after 82 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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.
19 later devices descend from it; 3 cite it directly.
0 of 20 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
- K142673: Bio-Medicus Adult Cannulae and Introducer (2014), 9 descendants of its own
- K052524: Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit (2005), 8 descendants of its own
- K180453: Bio-Medicus Adult Cannulae and Introducer (2018), 6 descendants of its own
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own

## Recalls of this device
- May 9, 2008 · Not classified · Z-1929-2008: 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/K884129
Methodology: https://510kreport.com/methodology