# K061546: Quart Arterial Filter with Safeline Coating, Model BSQ-HBF 140

- Pathway: 510(k) (Special)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Jun 20, 2006 after 15 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Jostra Quart Arterial Filter: named in the summary without a submission number
- (no number) Jostra RotaFlow Centrifugal Pump with Safeline Coating: named in the summary without a submission number

## Most influential descendants
- K090518: Quart Arterial Filter with Softline Coating (2009), 0 descendants of its own

## Indications for use
The Quart Arterial Filter with Safeline Coating is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, the arterial filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician. The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.

Source page: https://510kreport.com/device/K061546
Methodology: https://510kreport.com/methodology