Identity
- Trade Name
- Axium™ Prime Detachable Coil System FDA UDI
- Generic Name
- Neurovascular embolization coil FDA UDI
- Device Name
- COIL APB-2-1-HX-ES V11 FDA UDI
- Model / Reference
- APB-2-1-HX-ES FDA UDI
- Description
- COIL APB-2-1-HX-ES V11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000495138 FDA UDI
- 510(k) Number
- K203432 FDA UDI
- FDA Product Code
- HCG FDA UDIKRD FDA UDI
- GMDN Term
- Neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5950 FDA UDI870.3300 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
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
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- 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
K203432 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 |
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Manufacturer
- Manufacturer
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI 33011f72-447a-462b-ad82-05959952f315 36 fields · synced May 30, 2026