The following data is part of a premarket notification filed by Jostra Ag with the FDA for Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030.
| Device ID | K030264 |
| 510k Number | K030264 |
| Device Name: | QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | JOSTRA AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Katrin Schwenkglenks |
| Correspondent | Katrin Schwenkglenks JOSTRA AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-27 |
| Decision Date | 2003-02-26 |
| Summary: | summary |