The following data is part of a premarket notification filed by Dideco S.r.l. with the FDA for D732 Micro 27 Ph.i.s.i.o. Adult Arterial Filter.
| Device ID | K052717 |
| 510k Number | K052717 |
| Device Name: | D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | DIDECO S.R.L. 200 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.R.L. 200 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 | 2005-09-29 |
| Decision Date | 2005-10-20 |
| Summary: | summary |