The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for D735 Micro 20 And D736 Micro 40 Newborn-infant Arterial Filters.
| Device ID | K033987 |
| 510k Number | K033987 |
| Device Name: | D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | DIDECO S.P.A. 195 WEST ST. Waltham, MA 02451 -1163 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.P.A. 195 WEST ST. Waltham, MA 02451 -1163 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-23 |
| Decision Date | 2004-01-08 |
| Summary: | summary |