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K Number
K051060
Device Name
ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
Manufacturer
ANGIODYNAMICS, INC.
Date Cleared
2005-05-26

(30 days)

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

The ANGIODYNAMICS Profiler™ PTA Balloon Catheter is indicated for general Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not designed to be used in the coronary arteries.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Angiodynamics, Inc. regarding their Profiler™ PTA Balloon Catheter. This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot extract the requested information from the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed, subject to general controls. It does not detail specific performance studies or acceptance criteria for the device itself.

§ 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).