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K Number
K081878
Device Name
LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
Manufacturer
LEMAITRE VASCULAR, INC.
Date Cleared
2009-01-27

(209 days)

Product Code
DQY,DOY
Regulation Number
870.1250
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The TT® Introducer is used to introduce balloon catheters, closed-end catheters, and other vascular devices.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the LeMaitre TT® Tortuous Tracker Introducer Delivery System. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information.

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).