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Azur Detachable 18

FDA 510(k)

Class II (US FDA 510(k))

510(k) K120630

by Microvention Inc.

Identifiers

510(k) Number
K120630 FDA 510(k)
FDA Product Code
KRD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3300 FDA 510(k)
Regulation Number
870.3300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Azur Detachable 18 is a vascular embolization device designed for promoting embolization. It is a platinum alloy coil with a helical structure, available in various diameters and lengths, and is supplied with a delivery pusher and detachment controller system.

The device is intended for use in neurovascular embolization procedures. It is a single-use implant, provided non-sterile and requiring sterilization prior to use, and is regulated under FDA 510(k) clearance K120630 with product code KRD and regulation number 870.3300.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF 510(k) Summary Trade Name: Azur Detachable 18 MAR 1 2 2009, K162524 - AZUR CX Detachable 18 Peripheral Coil System, Available Now: FDA 510(k), K162524, AZUR CX Detachable 18 Peripheral ..., MAUDE Adverse Event Report: MICROVENTION INC AZUR-18 DETACHABLE ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Microvention Inc.
FDA Applicant
MicroVention, Inc.

Sources (1)

  • FDA 510(k) K120630 24 fields · synced Sep 23, 2026