The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Resubmitted Multiorgan Perfusion Cannula.
| Device ID | K902394 |
| 510k Number | K902394 |
| Device Name: | RESUBMITTED MULTIORGAN PERFUSION CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | FRESENIUS USA, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick, NJ 08903 |
| Contact | Ron Guido |
| Correspondent | Ron Guido FRESENIUS USA, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick, NJ 08903 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-30 |
| Decision Date | 1990-09-27 |