# K093601: AF 840 PH.I.S.I.O. Arterial Filter

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Dec 18, 2009 after 28 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.
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) 0734 MICRO 40 Ph.I.S.I.O. Adult Arterial Filter: named in the summary without a submission number

## Indications for use
The AF 840 Ph.l.S.I.O. Arterial Filter with 40 micron screen with phosphoryicholine coating is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours of use. The filter is effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.

Source page: https://510kreport.com/device/K093601
Methodology: https://510kreport.com/methodology