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K Number
K000409
Device Name
MODIFICATION TO T-REX BIOPSY FORCEPS
Manufacturer
BOSTON SCIENTIFIC CORP.
Date Cleared
2000-02-28

(20 days)

Product Code
DWZ
Regulation Number
870.4075
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.4075 Endomyocardial biopsy device.

(a)
Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.(b)
Classification. Class II (performance standards).