AZUR DETACHABLE 35 PLATINUM COIL SYSTEM

• K Number: K111307
• Device Name: AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
• Manufacturer: MICROVENTION, INC.
• Date Cleared: 2011-06-15 ( 36 days)
• Product Code: KRD
• Regulation Number: 870.3300
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

Device Description

Not Found

AI/ML Overview

This document is a letter from the FDA regarding the clearance of the AZUR Detachable 35 Platinum Coil System. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot provide the requested information based on this document.

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).