Identity
- Trade Name
- ConcertoTM FDA UDI
- Generic Name
- Non-neurovascular embolization coil FDA UDI
- Device Name
- NV-6-20-HELIX CONCERTO HELIX 6MMX20CM FDA UDI
- Model / Reference
- NV-6-20-HELIX FDA UDI
- Description
- NV-6-20-HELIX CONCERTO HELIX 6MMX20CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847536013582 FDA UDI
- 510(k) Number
- K090046 FDA UDI
- FDA Product Code
- KRD FDA UDI
- GMDN Term
- Non-neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 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
Ethylene Oxide FDA UDI
MR Conditional FDA UDI
Category: Non-neurovascular embolization coil
ConcertoTM by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-neurovascular embolization coil.
- Target — Stryker Corp. · Class II
- Prestige Coil System — BALT USA LLC · Class II
- Optima Coil System — BALT USA LLC · Class II
- Nester — COOK INCORPORATED · Class II
- TARGET — Stryker Corp. · Class II
- Penumbra Coil 400 — PENUMBRA, INC. · Class II
- GDC-10 — Stryker Corp. · Class II
- TARGET XL — Stryker Corp. · Class II
Cleared under the same submission
K090046 also covers:
- CONCERTO — Micro Therapeutics, Inc.
- CONCERTO — Micro Therapeutics, Inc.
- CONCERTO — Micro Therapeutics, Inc.
- CONCERTO — Micro Therapeutics, Inc.
- CONCERTO — Micro Therapeutics, Inc.
- CONCERTO — Micro Therapeutics, Inc.
- CONCERTO — Micro Therapeutics, Inc.
- CONCERTO — Micro Therapeutics, Inc.
- CONCERTO — Micro Therapeutics, Inc.
- CONCERTO — Micro Therapeutics, Inc.
- Concerto — Micro Therapeutics, Inc.
- Concerto — 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 b2df482c-1ae2-4622-8d63-178bcd115deb 36 fields · synced Jun 7, 2026