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K Number
K971314
Device Name
DCAT EMBOLECTOMY CATHETER SYSTEM
Manufacturer
ANGIODYNAMICS, INC.
Date Cleared
1998-03-17

(342 days)

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

The ANGIODYNAMICS, Inc. DCAT System is for the percutaneous isolation and aspiration of fresh thrombus from vessels in the vascular system. Additionally, it may also be used for temporary occlusion of blood vessels, isolated infusion of fluids, and blood sampling.

The ANGIODYNAMICS, Inc. Cohn Thrombectomy Catheter is intended to be used for temporary occlusion and removal of thromboemboli from native or synthetic vessels within the arterial circulation.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device. The document is a 510(k) clearance letter from the FDA for two thrombectomy catheter systems, and it primarily focuses on regulatory approval based on substantial equivalence to existing devices. It does not contain the specific technical or clinical study details you are asking for.

§ 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).