EXV VENOUS RESERVOIR BAG & HOLDER— 510(k) K823205

Name: FDA 510(k) clearance K823205
Creator: U.S. Food and Drug Administration
Published: 1982-11-24

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K823205 for EXV VENOUS RESERVOIR BAG & HOLDER, Substantially Equivalent on 1982-11-24. Applicant: Extracorporeal Medical Specialities, Inc.. Device class: 2.

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1982-10-27
Decision date: 1982-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K843955 — EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR1984-11-29
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K840532 — HEMOPERFUSION SYSTEM TP-4001984-05-30
K840057 — EXP* 500 PARALLEL PLATE DIALYZER1984-02-04
K840146 — EXP* 700 PARALLEL PLATE DIALYZER1984-02-04

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.