The following data is part of a premarket notification filed by Sorin Group Italia S.r.l with the FDA for Inspire 6m Hollow Fiber Oxygenator, Inspire 7m Hollow Fiber Oxygenator, Inspire 8m Hollow Fiber Oxygenator.
| Device ID | K201916 |
| 510k Number | K201916 |
| Device Name: | Inspire 6M Hollow Fiber Oxygenator, Inspire 7M Hollow Fiber Oxygenator, Inspire 8M Hollow Fiber Oxygenator |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Sorin Group Italia S.r.l Via Statale 12 Nord, 86 Mirandola, IT 41037 |
| Contact | Luigi Vecchi |
| Correspondent | Luigi Vecchi Sorin Group Italia S.r.l Via Statale 12 Nord, 86 Mirandola, IT 41037 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-10 |
| Decision Date | 2020-08-13 |