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K Number
K113300
Device Name
ATB ADVANCE PTA DILATATION CATHETER
Manufacturer
COOK, INC.
Date Cleared
2011-12-09

(30 days)

Product Code
LIT,DOY
Regulation Number
870.1250
Type
Special
Panel
CV
Reference & Predicate Devices
K033875,K052036,K063252
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents.

Device Description

The ATB Advance® PTA Dilatation Catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents. The 6 Fr balloon catheter will be compatible with a 0.035 inch wire guide and an 8 Fr sheath. It will be supplied sterile, intended for one-time use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ATB Advance® PTA Dilatation Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance CriteriaReported Device Performance
Balloon Minimum Burst Strength: Burst at or above the minimum rated burst pressure.Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. Predetermined acceptance criteria met.
Balloon Compliance: Meet labeled diameter within tolerance at the nominal pressure under simulated body temperature conditions.Testing shows that, under simulated body temperature conditions, each balloon will meet its labeled diameter within tolerance at the nominal pressure. Predetermined acceptance criteria met.
Balloon Profile: Compatible with an 8 Fr sheath (

§ 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).