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510(k) Data Aggregation

K Number

Device Name

CREATION NM DIAGNOSTIC CATHETERS

Manufacturer

NEICH MEDICAL (SHENZHEN) COMPANY LIMITED

Date Cleared

2004-02-24

(161 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

CREATION NM DIAGNOSTIC CATHETERS

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Neich Modical Creation NM™ Diagnostic Catheters are designed to deliver radiopaque contrast thediturn to selected sites in the vascular system,

Device Description

Creation NM™ Diagnostic Catheter

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a diagnostic catheter. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Therefore, I cannot provide the requested information based on the provided text.

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