Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Minjie Catheter System

K-Number: K212288 · 2022-06-02

ApplicantKai Medtech, LLC
Decision Date2022-06-02
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Minjie Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Kai Medtech, LLC. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K212288. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Minjie Catheter System?

Minjie Catheter System is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Kai Medtech, LLC. The 510(k) number is K212288.

When did Minjie Catheter System receive FDA 510(k) clearance?

Minjie Catheter System received FDA 510(k) clearance on 2022-06-02, under 510(k) number K212288.

Who is the listed applicant for Minjie Catheter System?

The FDA 510(k) record lists Kai Medtech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Minjie Catheter System?

The FDA product code for Minjie Catheter System is QJP.

Related Devices (Code: QJP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑