Identity
- Trade Name
- AXIUM FDA UDI
- Generic Name
- Neurovascular embolization coil FDA UDI
- Device Name
- Detachable Coil System FDA UDI
- Model / Reference
- NC-3-6-HELIX FDA UDI
- Description
- Detachable Coil System FDA UDI
Identifiers
- Catalog Number
- NC-3-6-HELIX FDA UDI
- Primary DI / UDI-DI
- 00836462011007 FDA UDI
- 510(k) Number
- K081465 FDA UDI
- FDA Product Code
- KRD FDA UDI
- GMDN Term
- Neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Centimeter FDA UDIOuter Diameter — 3 Millimeter FDA UDI
Category: Neurovascular embolization coil
Axium by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurovascular embolization coil.
- HydroSoft Helical — MICROVENTION INC. · Class II
- Target — Stryker Corp. · Class II
- WEB Aneurysm Embolization System — SEQUENT MEDICAL, INC. · Class III
- WEB Aneurysm Embolization System — MICROVENTION INC. · Class III
- HydroFill Helical — MICROVENTION INC. · Class II
- TARGET — Stryker Corp. · Class II
- HydroFill Helical — MICROVENTION INC. · Class II
- V-Trak — MICROVENTION INC. · Class II
Cleared under the same submission
K081465 also covers:
- AXIUM — Micro Therapeutics, Inc.
- AXIUM — Micro Therapeutics, Inc.
- AXIUM — Micro Therapeutics, Inc.
- AXIUM — Micro Therapeutics, Inc.
- Axium — Micro Therapeutics, Inc.
- Axium — Micro Therapeutics, Inc.
- Axium — Micro Therapeutics, Inc.
- Axium — Micro Therapeutics, Inc.
- Axium — Micro Therapeutics, Inc.
- Axium — Micro Therapeutics, Inc.
- Axium — Micro Therapeutics, Inc.
- Axium — Micro Therapeutics, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI 0a1bd639-d3b7-4d3d-b7c4-a6ee9946bd5b 37 fields · synced May 30, 2026