ACR 2500 CARDIOTOMY RESERVOIR FILTER— 510(k) K842391

Name: FDA 510(k) clearance K842391
Creator: U.S. Food and Drug Administration
Published: 1985-05-21

Substantially Equivalent

Electromedics, Inc.

FDA 510(k) clearance K842391 for ACR 2500 CARDIOTOMY RESERVOIR FILTER, Substantially Equivalent on 1985-05-21. Applicant: Electromedics, Inc.. Device class: 2.

Clearance details

Applicant: Electromedics, Inc.
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1984-06-18
Decision date: 1985-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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 Electromedics, Inc.

view all

K934964 — ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR1994-03-07
K933832 — ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR1994-01-28
K934355 — ELECTROMEDICS BLOOD HEAT EXCHANGER1993-12-03
K930154 — EL2-SERIES BLOOD COLLECTION REERVOIR1993-07-01
K926250 — ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR1993-02-19

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.