Minjie Catheter System— 510(k) K212288

Name: FDA 510(k) clearance K212288
Creator: U.S. Food and Drug Administration
Published: 2022-06-02

Substantially Equivalent

Kai Medtech, LLC

FDA 510(k) clearance K212288 for Minjie Catheter System, Substantially Equivalent on 2022-06-02. Applicant: Kai Medtech, LLC. Device class: 2.

Clearance details

Applicant: Kai Medtech, LLC
Product code: Code QJP
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2021-07-21
Decision date: 2022-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QJP

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K262277 — 70 NeuGlide Catheter2026-09-04
K261176 — Zoom 4S Catheter2026-08-28
K254071 — p17 XR Microcatheter2026-08-18
K260199 — SLIM Microcatheter2026-07-13
K253901 — Millipede88 Access Catheter2026-07-09

Adverse events under product code QJP

product code QJP

Death: 43
Injury: 233
Malfunction: 1,010
Total: 1,286

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.