The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Inspire 7fm Hollow Fiber Oxygenator With Integrated Arterial Filter, Inspire 7f Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Reservoir, Inspire 7f Dual Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Res.
| Device ID | K200683 |
| 510k Number | K200683 |
| Device Name: | INSPIRE 7FM Hollow Fiber Oxygenator With Integrated Arterial Filter, INSPIRE 7F Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Reservoir, INSPIRE 7F DUAL Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Res |
| 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 |
| Subsequent Product Code | DTM |
| Subsequent Product Code | DTN |
| Subsequent Product Code | DTP |
| Subsequent Product Code | DTR |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-16 |
| Decision Date | 2020-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178113367 | K200683 | 000 |
| 38033178113350 | K200683 | 000 |
| 38033178113343 | K200683 | 000 |