The following data is part of a premarket notification filed by Minntech Corp. with the FDA for William Harvey Hf5000 Membrane Oxygenator.
| Device ID | K934292 |
| 510k Number | K934292 |
| Device Name: | WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
| Contact | Susan Tesmer |
| Correspondent | Susan Tesmer MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-02 |
| Decision Date | 1994-07-26 |