The following data is part of a premarket notification filed by Medtronic Blood Systems, Inc. with the FDA for Maxima* Hollow Fiber Oxygenator W/filtered Reserv..
| Device ID | K891230 |
| 510k Number | K891230 |
| Device Name: | MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Sharon Rockwell |
| Correspondent | Sharon Rockwell MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-07 |
| Decision Date | 1989-05-19 |