# K924529: Signature (TM) Custom Tubing Pack

- Pathway: 510(k) (Traditional)
- Applicant: Avecor Cardiovascular, Inc.
- Decided: Jun 23, 1993 after 288 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## 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
- K151523: Uncoated Tubing and Connector Components (2015), 4 descendants of its own
- K171308: Tubing Pack (2017), 3 descendants of its own
- K171979: Tubing Pack (2017), 2 descendants of its own

## Recalls of this device
- Nov 16, 2016 · Class II · Z-0826-2017: Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combinati
- 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 

Source page: https://510kreport.com/device/K924529
Methodology: https://510kreport.com/methodology