SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045— 510(k) K022281

Name: FDA 510(k) clearance K022281
Creator: U.S. Food and Drug Administration
Published: 2002-08-06

Substantially Equivalent

Polystan A/S

FDA 510(k) clearance K022281 for SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045, Substantially Equivalent on 2002-08-06. Applicant: Polystan A/S. Device class: 2.

Clearance details

Applicant: Polystan A/S
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 2002-07-15
Decision date: 2002-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vaerlose, DK

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.