Identity
- Trade Name
- AxiumTM FDA UDI
- Generic Name
- Neurovascular embolization coil FDA UDI
- Device Name
- COIL APB-1.5-4-3D-ES V01 FDA UDI
- Model / Reference
- APB-1.5-4-3D-ES FDA UDI
- Description
- COIL APB-1.5-4-3D-ES V01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847536021822 FDA UDI
- 510(k) Number
- K151447 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
- Not 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
Ethylene Oxide FDA UDI
MR Conditional FDA UDI
AxiumTM by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K151447 also covers:
- Axium Prime Detachable Coil System — Micro Therapeutics, Inc.
- Axium Prime Detachable Coil System — Micro Therapeutics, Inc.
- Axium Prime Detachable Coil System — Micro Therapeutics, Inc.
- Axium Prime Detachable Coil System — Micro Therapeutics, Inc.
- Axium Prime Detachable Coil System — Micro Therapeutics, Inc.
- Axium Prime Detachable Coil System — Micro Therapeutics, Inc.
- Axium Prime Detachable Coil System — Micro Therapeutics, Inc.
- Axium Prime Detachable Coil System — Micro Therapeutics, Inc.
- Axium Prime Detachable Coil System — Micro Therapeutics, Inc.
- Axium Prime Detachable Coil System — Micro Therapeutics, Inc.
- Axium Prime Detachable Coil System — Micro Therapeutics, Inc.
- Axium Prime 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 |
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Manufacturer
- Manufacturer
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI d53943e2-0fdd-4d0f-bce4-d053c5f923cf 37 fields · synced Jun 1, 2026