MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)

• K Number: K952984
• Device Name: MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)
• Manufacturer: MAP MEDICAL EQUIPMENT, INC.
• Date Cleared: 1996-01-29 ( 215 days)
• Product Code: DQO
• Regulation Number: 870.1200
• Type: Traditional
• Panel: Cardiovascular
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K040830

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).