The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Revolution Centrifugal Blood Pump.
| Device ID | K190650 |
| 510k Number | K190650 |
| Device Name: | Revolution Centrifugal Blood Pump |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | SORIN GROUP ITALIA S.R.L. Via Statale 12 Nord, 86 Mirandola, IT 41037 |
| Contact | Luigi Vecchi |
| Correspondent | Scott Light LivaNova USA, Inc. 14401 West 65th Way Arvada, CO 80004 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-13 |
| Decision Date | 2019-08-07 |