The following data is part of a premarket notification filed by Levitronix Llc. with the FDA for Levitronix Pedimag Blood Pump, Model 201-90052.
| Device ID | K090051 |
| 510k Number | K090051 |
| Device Name: | LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | LEVITRONIX LLC. 45 FIRST AVE. Waltham, MA 02451 |
| Contact | Susan Hamann |
| Correspondent | Susan Hamann LEVITRONIX LLC. 45 FIRST AVE. Waltham, MA 02451 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-07 |
| Decision Date | 2009-10-08 |
| Summary: | summary |