The following data is part of a premarket notification filed by Dideco S.r.l. with the FDA for D731 Micro 20 Ph.i.s.i.o Pediatric Arterial Filter, D733 Micro 40 Ph.i.si.o Pediatric Arterial Filter.
| Device ID | K051232 |
| 510k Number | K051232 |
| Device Name: | D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | DIDECO S.R.L. 195 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.R.L. 195 WEST STREET Waltham, MA 02451 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-13 |
| Decision Date | 2005-05-20 |
| Summary: | summary |