CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING— 510(k) K061527

Name: FDA 510(k) clearance K061527
Creator: U.S. Food and Drug Administration
Published: 2006-06-27

Substantially Equivalent

Sorin 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: Product code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 2006-06-02
Decision date: 2006-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTN

view all

K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs2025-12-22
K241206 — Quantum Perfusion Hybrid System2024-07-18
K241053 — MVR Venous Reservoir Bag 800 mL +3 more2024-05-15
K223361 — BMR 1900 PHISIO2023-06-10
K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface2017-03-17

More clearances from Sorin Group Italia S.R.L.

view all

K263092 — Dual Stage Venous Cannulae2026-10-01
K262052 — Tri Stage Venous Cannulae2026-09-28
K253671 — Dual Stage Venous Cannulae2026-01-30
K253616 — ProtekDilate Vascular Access Kit2025-12-19
K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)2025-06-27

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.