SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR— 510(k) K092315
Substantially EquivalentSorin Group Italia S.R.L.
FDA 510(k) clearance K092315 for SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR, Substantially Equivalent on 2009-08-12. Applicant: Sorin Group Italia S.R.L.. Device class: 2.
Clearance details
- Applicant
- Sorin Group Italia S.R.L.
- Product code
- Code DTN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4400
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waltham, MA, US
Recent devices under product code DTN
view allMore clearances from Sorin Group Italia S.R.L.
view all- K253671 — Dual Stage Venous Cannulae
- K253616 — ProtekDilate Vascular Access Kit
- K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
- K250150 — VANGUARD Blood cardioplegia Systems (3 models)
- K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
Adverse events under product code DTN
product code DTN- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.