LogoFDA 510(k) Search
K Number
K000409

Validate with FDA (Live)

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
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 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).