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Concerto Detachable Coil System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K090046

by Micro Therapeutics, Inc.

Identity

Trade Name
Concerto Detachable Coil System FDA UDI
Generic Name
Non-neurovascular embolization coil FDA UDI
Device Name
COIL PV-2-4-3D V05 FDA UDI
Model / Reference
PV-2-4-3D FDA UDI
Description
COIL PV-2-4-3D V05 FDA UDI

Identifiers

Primary DI / UDI-DI
00847536045088 FDA UDI
510(k) Number
K090046 FDA 510(k)FDA UDI
FDA Product Code
KRD FDA 510(k)FDA UDI
GMDN Term
Non-neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 870.3300 FDA 510(k)
Regulation Number
870.3300 FDA 510(k)FDA UDI
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Concerto Detachable Coil System by Micro Therapeutics, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Micro Therapeutics, Inc.

Sources (2)

  • FDA 510(k) K090046 24 fields · synced Jun 18, 2026
  • FDA UDI acba018a-1df9-4d20-9f1f-8ed016675bb9 36 fields · synced May 27, 2026