ANGIOVAC CANNULA— 510(k) K133445

Name: FDA 510(k) clearance K133445
Creator: U.S. Food and Drug Administration
Published: 2014-03-05

Substantially Equivalent

Vortex Medical, Inc.

FDA 510(k) clearance K133445 for ANGIOVAC CANNULA, Substantially Equivalent on 2014-03-05. Applicant: Vortex Medical, Inc.. Device class: 2.

Clearance details

Applicant: Vortex Medical, Inc.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 2013-11-12
Decision date: 2014-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vortex Medical, Inc.

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K092486 — VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT2009-08-28
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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.