# K033328: Novosci Tubing and Connectors with Novocoat Treatment

- Pathway: 510(k) (Traditional)
- Applicant: Novosci Corp.
- Decided: Jan 16, 2004 after 92 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NovoSci Duraflo treated tubing and connectors: named in the summary without a submission number

## Indications for use
The NovoSciTM NovoCoatTM treated tubing and connectors are indicated for use in cardiopulmonary surgical procedures requiring extracorporeal support for periods up to 6 hours.

Source page: https://510kreport.com/device/K033328
Methodology: https://510kreport.com/methodology