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 Hardshell Venous/cardiotomy Reservoir.
| Device ID | K113626 |
| 510k Number | K113626 |
| Device Name: | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP ITALIA S.R.L. 195 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall SORIN GROUP ITALIA S.R.L. 195 WEST STREET Waltham, MA 02451 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-08 |
| Decision Date | 2012-04-05 |
| Summary: | summary |