# K981628: Bard Quantum SVR Model Number H-6440VR

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 5, 1998 after 90 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- 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 K920774 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935717: Affinity Venous Reservior Bag, Avecor Cardiovascular, Inc. (1994) Summary page 1.
- K920774: MVR Collapsible Venous Reservoir Bag, Medtronic Vascular (1992) Summary page 1.

## Indications for use
The Bard® Quantum™ SVR is designed to function in an extracorporeal circuit. The flexible venous reservoir receives dynamic blood from: (1) venous return (2) suctioned blood from the cardiotomy reservoir The venous reservoir stores this blood prior to returning it to the circuit. The Bard® Quantum™ SVR is designed to function for up to 6 hours in an extracorporeal circuit.

Source page: https://510kreport.com/device/K981628
Methodology: https://510kreport.com/methodology