The following data is part of a premarket notification filed by Orqis Medical Corporation with the FDA for Orqis Extracorporeal Blood Pumping System, Model Bps-100.
| Device ID | K073631 |
| 510k Number | K073631 |
| Device Name: | ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100 |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | ORQIS MEDICAL CORPORATION 14 ORCHARD ROAD, SUITE 100 Lake Forest, CA 92630 |
| Contact | Ryan Kelly |
| Correspondent | Ryan Kelly ORQIS MEDICAL CORPORATION 14 ORCHARD ROAD, SUITE 100 Lake Forest, CA 92630 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-06-27 |
| Summary: | summary |