# K052717: D732 Micro 27 PH.I.S.I.O. Adult Arterial Filter

- Pathway: 510(k) (Special)
- Applicant: Dideco S.R.L.
- Decided: Oct 20, 2005 after 21 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
Longest line of descent: 1 generation back to K952270 (1995). 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)
- K952270: Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron Screen, Sorin Biomedical, Inc. (1995) Summary page 2.
- K002493: Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation) Newborn/Infant Arterial Filter, Cobe Cardiovascular, Inc. (2000) Summary page 2.

## Indications for use
The Dideco D732 MICRO 27 Ph.I.S.I.O. with 27 micron screen with phosphorylcholine coating is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filter it is used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

Source page: https://510kreport.com/device/K052717
Methodology: https://510kreport.com/methodology