CARDIOTOMY RESERVOIRS— 510(k) K820727

Name: FDA 510(k) clearance K820727
Creator: U.S. Food and Drug Administration
Published: 1982-07-08

Substantially Equivalent

Erik Perfusion Services

FDA 510(k) clearance K820727 for CARDIOTOMY RESERVOIRS, Substantially Equivalent on 1982-07-08. Applicant: Erik Perfusion Services. Device class: 2.

Clearance details

Applicant: Erik Perfusion Services
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1982-03-17
Decision date: 1982-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code DTN

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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

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.