The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Sorin Vvr 4000i And 4000i Smarxt Filtered Hardshell Venous Reservoir.
| Device ID | K092315 |
| 510k Number | K092315 |
| Device Name: | SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sail |
| Correspondent | Barry Sail SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham, MA 02451 |
| Product Code | DTN |
| Subsequent Product Code | DTP |
| Subsequent Product Code | JOD |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-30 |
| Decision Date | 2009-08-12 |
| Summary: | summary |