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K Number
K021129
Device Name
CHARE CARIOVASCULAR PATCH
Manufacturer
CHASE MEDICAL, INC.
Date Cleared
2002-06-03

(56 days)

Product Code
DXZ
Regulation Number
870.3470
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CHASE Cardiovascular Patch With Radiopaque Markings is indicated for cardiac and vascular patch grafting.

Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. This document is an FDA 510(k) clearance letter for a medical device called "Cardiovascular Patch With Radiopaque Markings," indicating it has been deemed substantially equivalent to a legally marketed predicate device. It does not include the details of a study with acceptance criteria and performance metrics.

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).