The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Af 840 Ph.i.s.i.o. Arterial Filter.
| Device ID | K093601 |
| 510k Number | K093601 |
| Device Name: | AF 840 PH.I.S.I.O. ARTERIAL FILTER |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | SORIN GROUP ITALIA S.R.L. 195 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall SORIN GROUP ITALIA 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 | 2009-11-20 |
| Decision Date | 2009-12-18 |
| Summary: | summary |