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K Number
K992934
Device Name
LEMAITRE VENOUS THROMBECTOMY CATHETER
Manufacturer
VASCUTECH, INC.
Date Cleared
2000-03-01

(183 days)

Product Code
DXE
Regulation Number
870.5150
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LeMaitre Venous Thrombectomy Catheter is indicated for the removal of venous thrombi.

Device Description

Not Found

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "LeMaitre Venous Thrombectomy Catheter". The letter primarily addresses the substantial equivalence of the device to legally marketed predicate devices and grants permission to market the device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot provide the requested information based on the given text. The document is a regulatory approval letter, not a study report.

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).