The following data is part of a premarket notification filed by Sorin Group Italia S.r.l with the FDA for D130 Ph.i.s.i.o Dideco Kids Neonatal Arterial Filter With 40 Micron Screen Phosphorylcholine Coated.
| Device ID | K063255 |
| 510k Number | K063255 |
| Device Name: | D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | SORIN GROUP ITALIA S.R.L 200 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall SORIN GROUP ITALIA S.R.L 200 WEST STREET Waltham, MA 02451 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-27 |
| Decision Date | 2007-01-11 |
| Summary: | summary |