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Sapphire VDS Tension Safe Detachable Coil, E-3-12/3-T10-VT

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032497

by Micro Therapeutics, Inc.

Identifiers

510(k) Number
K032497 FDA 510(k)
FDA Product Code
HCG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5950 FDA 510(k)
Regulation Number
882.5950 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a neurovascular embolization coil system, consisting of a platinum alloy wire wound into a primary coil and secondary helical shape with multiple segments and polymer caps. It is designed for endovascular embolization procedures in the neurovascular system.

The coil is welded to a positioning wire with a stainless steel core and Teflon jacket, and detachment is achieved using a battery-operated power supply. It is supplied as a sterile, single-use device intended for use by neurosurgeons in clinical settings. The device received FDA 510(k) clearance (K032497) under regulation 882.5950, classified as a Class II device with product code HCG, and is authorized for neurovascular embolization.

Frequently asked questions

What is the SAPPHIRE VDS Tension Safe Detachable Coil used for?

This device is designed for endovascular embolization procedures in the neurovascular system, where it is deployed to occlude blood flow in intracranial aneurysms or other vascular malformations by forming a stable platinum alloy coil mass within the vessel lumen.

How is the SAPPHIRE VDS coil supplied and is it reusable?

The coil is supplied as a sterile, single-use device; it is intended for one-time use only and must not be resterilized or reused, as doing so could compromise structural integrity, increase infection risk, and violate the manufacturer’s instructions and regulatory clearance.

What components make up the SAPPHIRE VDS coil system and how is it detached?

The system includes a platinum alloy wire wound into a primary coil and secondary helical shape with polymer caps, welded to a positioning wire with a stainless steel core and Teflon jacket; detachment from the wire is achieved using a battery-operated power supply that triggers electrolytic separation at the weld point.

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: Sapphire Vds Tension Safe Detachable Coil, E-3-12/3-t10-vt, SAPPHIRE VDS TENSION SAFE DETACHABLE COIL… - FDA.report, SAPPHIRE VDS TENSION SAFE DETACHABLE COIL… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Micro Therapeutics, Inc.

Sources (1)

  • FDA 510(k) K032497 24 fields · synced Oct 6, 2026