# K964205: Better-Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Circulatory Technology, Inc.
- Decided: Apr 8, 1998 after 537 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K803277 (1981). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K803277: Tygon Tubing, Electromedics, Inc. (1981) Summary page 3.

## Most influential descendants
- K041650: Micro Prime (2004), 0 descendants of its own

## Indications for use
The Better-Tubing™ is designed for use as a blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.

Source page: https://510kreport.com/device/K964205
Methodology: https://510kreport.com/methodology