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 6f M Hollow Fiber Oxygenator With Integrated Arterial Filter; Inspire 8m Hollow Fiber Oxygenator; Inspire 8f M Hollow Fiber Oxygenator With Integrated Arterial Filter.
| Device ID | K180448 |
| 510k Number | K180448 |
| Device Name: | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator With Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator With Integrated Arterial Filter |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Sorin Group Italia S.r.l 86, Via Statale 12 Nord Mirandola, IT 41037 |
| Contact | Luigi Vecchi |
| Correspondent | Scott Light LivaNova USA, Inc. 14401 West 65th Way Arvada, CO 80004 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-13 |
| Decision Date | 2018-03-15 |
| Summary: | summary |