# K962726: Bard Quantum CVR

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 30, 1996 after 107 days
- Product code: DTP (Defoamer, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4230
- 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 K902856 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902856: Bard Filtered Cardiotomy Reservoir, C.R. Bard, Inc. (1990) Summary page 1.
- (no number) Cobe HVRF®-3700 Open Venous Reservoir with Integral Cardiotomy Filter: named in the summary without a submission number

## Indications for use
The Bard® Quantum™ CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from: venous return, intracardiac suction, ventricular vent devices, and arterial-venous shunts. It defoams, filters and stores this blood before returning it to the circuit.

Source page: https://510kreport.com/device/K962726
Methodology: https://510kreport.com/methodology