# K990514: Modification of Bard Quantum CVR, Model H-6770VR

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 9, 1999 after 19 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Bard Quantum CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from: 1) Venous return; 2) Intracardiac suction; 3) Ventricular vent devices; 4) Arterial-venous shunts. It defoams, filters and stores this blood prior to returning it to the circuit.

Source page: https://510kreport.com/device/K990514
Methodology: https://510kreport.com/methodology