LANDMARK REBOA Catheter— 510(k) K214060

Name: FDA 510(k) clearance K214060
Creator: U.S. Food and Drug Administration
Published: 2022-09-19

Substantially Equivalent

Zien Medical Technologies, Inc.

FDA 510(k) clearance K214060 for LANDMARK REBOA Catheter, Substantially Equivalent on 2022-09-19. Applicant: Zien Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Zien Medical Technologies, Inc.
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 2021-12-27
Decision date: 2022-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.