LimFlow V-Ceiver— 510(k) K222083

Name: FDA 510(k) clearance K222083
Creator: U.S. Food and Drug Administration
Published: 2022-08-09

Substantially Equivalent

LimFlow, Inc.

FDA 510(k) clearance K222083 for LimFlow V-Ceiver, Substantially Equivalent on 2022-08-09. Applicant: LimFlow, Inc.. Device class: 2.

Clearance details

Applicant: LimFlow, Inc.
Product code: Code MMX
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2022-07-15
Decision date: 2022-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MMX

product code MMX

Death: 3
Total: 3

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.