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K Number
K964467
Device Name
SHELHIGH PERICARDIAL PATCH
Manufacturer
SHELHIGH, INC.
Date Cleared
1997-09-23

(320 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 Shelhigh Pericardial Patch is intended for use as a pericardial patch, and as an intracardiac patch.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the "Shelhigh Pericardial Patch (without detoxification treatment)" and an "Indications for Use" statement. It does not contain information about acceptance criteria, device performance studies, or the methodologies used to establish such criteria and conduct studies.

Therefore, I cannot provide the requested information based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not delve into the technical details of its performance or the studies behind it.

§ 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).