Identity
- Trade Name
- Axium™ Prime Detachable Coil System FDA UDI
- Generic Name
- Neurovascular embolization coil FDA UDI
- Device Name
- COIL FC-10-40-3D V14 FDA UDI
- Model / Reference
- FC-10-40-3D FDA UDI
- Description
- COIL FC-10-40-3D V14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000847678 FDA UDI
- 510(k) Number
- K233420 FDA UDI
- FDA Product Code
- KRD FDA UDIHCG FDA UDI
- GMDN Term
- Neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI882.5950 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Neurovascular embolization coil
Axium™ Prime Detachable Coil System 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
K233420 also covers:
- Axium™ Detachable Coil System — Micro Therapeutics, Inc.
- Axium™ Detachable Coil System — Micro Therapeutics, Inc.
- Axium™ Detachable Coil System — Micro Therapeutics, Inc.
- Axium™ Detachable Coil System — Micro Therapeutics, Inc.
- Axium™ Detachable Coil System — Micro Therapeutics, Inc.
- Axium™ Detachable Coil System — Micro Therapeutics, Inc.
- Axium™ Detachable Coil System — Micro Therapeutics, Inc.
- Axium™ Detachable Coil System — Micro Therapeutics, Inc.
- Axium™ Detachable Coil System — Micro Therapeutics, Inc.
- Axium™ Detachable Coil System — Micro Therapeutics, Inc.
- Axium™ Detachable Coil System — Micro Therapeutics, Inc.
- Axium™ Detachable Coil System — 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 da285c4c-7fd8-4e3f-9ced-70e4e543d6c3 36 fields · synced May 30, 2026