# K964043: Cobe Optima and Cobe CML Duo Membrane Oxygenators

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Sep 29, 1997 after 355 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- 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) COBE® Optima™ Hollow Fiber Membrane Oxygenator: named in the summary without a submission number
- (no number) COBE® CML Duo™ Flat Sheet Membrane Oxygenator: named in the summary without a submission number

## Indications for use
The Optima™ and CML Duo™ are intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

Source page: https://510kreport.com/device/K964043
Methodology: https://510kreport.com/methodology