NOVAPORT ONE VASCULAR ACCESS CANNULA— 510(k) K112565

Name: FDA 510(k) clearance K112565
Creator: U.S. Food and Drug Administration
Published: 2011-12-06

Substantially Equivalent

Novalung GmbH

FDA 510(k) clearance K112565 for NOVAPORT ONE VASCULAR ACCESS CANNULA, Substantially Equivalent on 2011-12-06. Applicant: Novalung GmbH. Device class: 2.

Clearance details

Applicant: Novalung GmbH
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 2011-09-02
Decision date: 2011-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.