The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Apex Hp M Ph.i.s.i.o. Adult Hollow Fiber Membrane Oxygenator.
| Device ID | K083021 |
| 510k Number | K083021 |
| Device Name: | APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham, MA 02451 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-09 |
| Decision Date | 2008-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178109926 | K083021 | 000 |
| 38033178109902 | K083021 | 000 |