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510(k) Data Aggregation

K Number

Device Name

CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER

Manufacturer

Date Cleared

2002-12-18

(23 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Reference & Predicate Devices

Why did this record match?

Reference Devices :

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The Cordis Maxi LD Large Balloon Dilatation Catheter is intended for use in the dilatation of strictures of the esophagus.

Device Description

The device is an over the wire balloon catheter, with a distal balloon and a proximal hub. The balloon features two radiopaque marker bands.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) summary for the Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, a medical device for dilating esophageal strictures. It primarily focuses on demonstrating substantial equivalence to predicate devices, not on quantitative performance metrics or studies using test sets, expert ground truth, or AI.

Therefore, I cannot provide the requested information in the table format because the details are not present in the given text.

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