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SpiderX Embolic Protection Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K053195

by Ev3, Inc

Identifiers

510(k) Number
K053195 FDA 510(k)
FDA Product Code
NFA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SpiderX Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. It contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFE-coated 0.014" stainless steel wire, and a dual-ended SpiderX Catheter. The device is used as a guidewire and embolic protection system to contain and remove embolic material.

The SpiderX Embolic Protection Device is intended for use in conjunction with the TurboHawk peripheral plaque excision system in the treatment of severely calcified lesions in arteries of the lower extremities. It is supplied as a single-use device and requires specific storage conditions. The device has received FDA 510(k) clearance with product code NFA and is classified as a Class II medical device.

Frequently asked questions

What is the SpiderX Embolic Protection Device used for?

The SpiderX Embolic Protection Device is used as a guidewire and embolic protection system to contain and remove embolic material during peripheral interventions. It is specifically intended for use with the TurboHawk peripheral plaque excision system in the treatment of severely calcified lesions in arteries of the lower extremities.

How is the SpiderX Embolic Protection Device supplied and is it reusable?

The SpiderX Embolic Protection Device is supplied as a single-use device and is not intended for reuse. It must be discarded after one procedure to ensure patient safety and maintain device integrity, as reuse could compromise sterility and function.

What guidewire sizes is the SpiderX Embolic Protection Device compatible with?

The SpiderX Embolic Protection Device can be delivered over any 0.014

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: SpiderFX™ embolic protection device - Medtronic, PDF AUG I 1 Z005 510(k) Summary SpideRXIM Embolic Protection Device, K053195 FDA 510 (k) - SPIDERX EMBOLIC PROTECTION DEVICE

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ev3, Inc
FDA Applicant
Ev3, Inc.

Sources (1)

  • FDA 510(k) K053195 24 fields · synced Sep 27, 2026