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K Number
K032888
Device Name
CREATION NM DIAGNOSTIC CATHETERS
Manufacturer
NEICH MEDICAL (SHENZHEN) COMPANY LIMITED
Date Cleared
2004-02-24

(161 days)

Product Code
DQO
Regulation Number
870.1200
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
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.

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).