# K033987: D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial Filters

- Pathway: 510(k) (Special)
- Applicant: Dideco S.P.A.
- Decided: Jan 8, 2004 after 16 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 K961869 (1996). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961869: Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40, Sorin Biomedical, Inc. (1996) Summary page 1.
- K002493: Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation) Newborn/Infant Arterial Filter, Cobe Cardiovascular, Inc. (2000) Summary page 1.

## Most influential descendants
- K063255: D130 PH.I.S.I.O Dideco Kids Neonatal Arterial Filter with 40 Micron Screen Phosphorylcholine Coated (2007), 2 descendants of its own
- K072308: D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron Screen Phosphorycholine Coated (2007), 1 descendant of its own
- K242953: KIDS Arterial Filters (2024), 0 descendants of its own
- K242092: MICRO Arterial Filters (2024), 0 descendants of its own

## Indications for use
The Dideco D735 MICRO 20 with 20 micron screen and the Dideco D736 MICRO 40 with 40 micron screen are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are 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/K033987
Methodology: https://510kreport.com/methodology