The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Inspire 6 Hollow Fiber Oxygenator With Integrated Hardhell Reservoir, Inspire 6f Hollow Fiber Oxygenator With Integrated.
| Device ID | K130209 |
| 510k Number | K130209 |
| Device Name: | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP ITALIA S.R.L. 14401 W. 65TH WAY Arvada, CO 80004 |
| Contact | Scott Light |
| Correspondent | Scott Light SORIN GROUP ITALIA S.R.L. 14401 W. 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 | 2013-01-29 |
| Decision Date | 2013-02-12 |
| Summary: | summary |