# K012538: Tubing and Connectors with Trillium Biopassive Surface

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Aug 23, 2001 after 16 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K800178 (1980). 1 ancestor in all.
14 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800178: Extracorp.'S Intersept Cus. Tubing PK., Extracorporeal Medical Specialities, Inc. (1980) Summary page 1.

## Most influential descendants
- K113845: Tubing, Conmnectors, and Accessories Wit Balance Biosurface (2012), 7 descendants of its own
- K122811: Connector Components with Balance Biosurface (2012), 5 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
- K151523: Uncoated Tubing and Connector Components (2015), 4 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
- Feb 4, 2016 · Class III · Z-1023-2016: Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems 
- Oct 28, 2015 · Class II · Z-0268-2016: This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag
- Aug 18, 2015 · Class II · Z-2736-2015: Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone device
- Jul 17, 2013 · Class II · Z-2106-2013: Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactu
- Nov 19, 2012 · Class II · Z-0618-2013: Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can 

## Indications for use
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.

Source page: https://510kreport.com/device/K012538
Methodology: https://510kreport.com/methodology