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Axium™ Detachable Coil System

FDA UDI

Class II (US FDA UDI)

by Micro Therapeutics, Inc.

Identity

Trade Name
Axium™ Detachable Coil System FDA UDI
Generic Name
Neurovascular embolization coil FDA UDI
Device Name
COIL PC-6-10-3D V12 FDA UDI
Model / Reference
PC-6-10-3D FDA UDI
Description
COIL PC-6-10-3D V12 FDA UDI

Identifiers

Primary DI / UDI-DI
00763000489205 FDA UDI
510(k) Number
K203432 FDA UDI
FDA Product Code
HCG FDA UDI
KRD FDA UDI
GMDN Term
Neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5950 FDA UDI
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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Neurovascular embolization coil

Axium™ 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.

Cleared under the same submission

K203432 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micro Therapeutics, Inc.

Sources (1)

  • FDA UDI 7d916b14-6770-4596-9f26-9b454b0f847b 36 fields · synced May 30, 2026