V2K Rinspiration System— 510(k) K172716

Name: FDA 510(k) clearance K172716
Creator: U.S. Food and Drug Administration
Published: 2018-01-26

Substantially Equivalent

V2k Medical, Inc.

FDA 510(k) clearance K172716 for V2K Rinspiration System, Substantially Equivalent on 2018-01-26. Applicant: V2k Medical, Inc.. Device class: 2.

Clearance details

Applicant: V2k Medical, Inc.
Product code: Code QEW
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2017-09-08
Decision date: 2018-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

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.