Identity
- Trade Name
- SpiderFX™ FDA UDI
- Generic Name
- Embolic protection filtering guidewire FDA UDI
- Device Name
- EP SPD2-US-030-190 SPIDER FX V04 FDA UDI
- Model / Reference
- SPD2-US-030-190 FDA UDI
- Description
- EP SPD2-US-030-190 SPIDER FX V04 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821684068298 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.0 Millimeter FDA UDILength — 190.0 Centimeter FDA UDI
SpiderFX™ by Ev3, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K063204 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 74537996-fe0e-4549-9551-22670637d85a 38 fields · synced Jun 8, 2026