SpiderFX™

FDA UDI

Class II (US FDA UDI)

by Ev3, Inc

Identity

Trade Name: SpiderFX™ FDA UDI
Generic Name: Embolic protection filtering guidewire FDA UDI
Device Name: EP SPD2-US-070-320 SPIDER FX V04 FDA UDI
Model / Reference: SPD2-US-070-320 FDA UDI
Description: EP SPD2-US-070-320 SPIDER FX V04 FDA UDI

Identifiers

Primary DI / UDI-DI: 00821684068380 FDA UDI
510(k) Number: K063204 FDA UDI
K111010 FDA UDI
FDA Product Code: NTE FDA UDI
GMDN Term: Embolic protection filtering guidewire FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 7.0 Millimeter FDA UDI
Length — 320.0 Centimeter FDA UDI

Category: Embolic protection filtering guidewire

SpiderFX™ by Ev3, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SpiderFX — Covidien LP · Class II

Cleared under the same submission

K063204 also covers:

K111010 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ev3, Inc

Sources (1)

FDA UDI 9faa72e8-3f34-4e7a-99a3-6cfb08f37a1e 37 fields · synced May 30, 2026