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K Number
K961763
Device Name
PULSE*SPRAY INFUSION SYSTEM
Manufacturer
ANGIODYNAMICS, DIV. E-Z-EM, INC.
Date Cleared
1996-07-17

(71 days)

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

The Pulse*Spray ® System, PRO™ Infusion Catheter, and its related components, are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics and contrast media, into the peripheral vasculature.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Pulse*Spray Infusion System." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily addresses the regulatory classification and clearance of the device based on its substantial equivalence to previously marketed devices.

Therefore, I cannot provide the requested information.

§ 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).