The following data is part of a premarket notification filed by Parexelinternational with the FDA for D731 Micro 27 Ph.i.s.i.o. And D733 Micro 40 Ph.i.s.o. Arterial Filters.
| Device ID | K112525 |
| 510k Number | K112525 |
| Device Name: | D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | PAREXELINTERNATIONAL 195 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall PAREXELINTERNATIONAL 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 | 2011-08-31 |
| Decision Date | 2011-09-29 |
| Summary: | summary |