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K Number
K051655
Device Name
ANGIODYNAMICS, INC., MICRO ACCESS KITS
Manufacturer
ANGIODYNAMICS, INC.
Date Cleared
2005-09-12

(83 days)

Product Code
DQR,DQX,DRC,DYB
Regulation Number
870.1300
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AngioDynamics, Inc. Micro Access Kit is indicated for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA. It does not contain information regarding acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications. It only states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

Therefore, I cannot fulfill your request for the specific information outlined.

§ 870.1300 Catheter cannula.

(a)
Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.(b)
Classification. Class II (performance standards).