Michler-Kapp Cardiovascular Vent Catheter— 510(k) K200289

Name: FDA 510(k) clearance K200289
Creator: U.S. Food and Drug Administration
Published: 2021-01-28

Substantially Equivalent

Kapp Surgical Instrument, Inc.

FDA 510(k) clearance K200289 for Michler-Kapp Cardiovascular Vent Catheter, Substantially Equivalent on 2021-01-28. Applicant: Kapp Surgical Instrument, Inc.. Device class: 2.

Clearance details

Applicant: Kapp Surgical Instrument, Inc.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 2020-02-05
Decision date: 2021-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warrensville, OH, 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.