CARDIOTOMY RESERVOIR-FILTER 050-108-050— 510(k) K832671

Name: FDA 510(k) clearance K832671
Creator: U.S. Food and Drug Administration
Published: 1983-12-27

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K832671 for CARDIOTOMY RESERVOIR-FILTER 050-108-050, Substantially Equivalent on 1983-12-27. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1983-08-09
Decision date: 1983-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.