The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Inspire 7 Hollow Fiber Oxygenator With Integrated Hardshell/venous Cardiotomy Reservoir, Inspire 7m Hollow Fiber Oxygenator, Inspire 7 Dual Hollow Fiber Oxygenator With Integrated Hardshell/venous Cardiotomy Reservoir.
| Device ID | K190690 |
| 510k Number | K190690 |
| Device Name: | INSPIRE 7 Hollow Fiber Oxygenator With Integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator With Integrated Hardshell/Venous Cardiotomy Reservoir |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| 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 | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-03-18 |
| Decision Date | 2019-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178113237 | K190690 | 000 |
| 38033178113213 | K190690 | 000 |
| 38033178113183 | K190690 | 000 |