CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING— 510(k) K061527
Substantially EquivalentSorin Group Italia S.R.L.
FDA 510(k) clearance K061527 for CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING, Substantially Equivalent on 2006-06-27. 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.