Identity
- Trade Name
- Solitaire FDA UDI
- Generic Name
- Vascular implant detacher, electronic, reusable FDA UDI
- Device Name
- Detachment System FDA UDI
- Model / Reference
- NDS-1 FDA UDI
- Description
- Detachment System FDA UDI
Identifiers
- Catalog Number
- NDS-1 FDA UDI
- Primary DI / UDI-DI
- 00836462018242 FDA UDI
- 510(k) Number
- K041649 FDA UDI
- FDA Product Code
- HCG FDA UDI
- GMDN Term
- Vascular implant detacher, electronic, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular implant detacher, electronic, reusable
Solitaire by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular implant detacher, electronic, reusable.
- Penlight — Rashman Corp. · Class I
- SapphireTM — Micro Therapeutics, Inc. · Class II
Cleared under the same submission
K041649 also covers:
- NXT — Micro Therapeutics, Inc.
- NXT — Micro Therapeutics, Inc.
- NXT — Micro Therapeutics, Inc.
- NXT — Micro Therapeutics, Inc.
- NXT — Micro Therapeutics, Inc.
- NXT — Micro Therapeutics, Inc.
- NXT — Micro Therapeutics, Inc.
- NXT — Micro Therapeutics, Inc.
- NXT — Micro Therapeutics, Inc.
- NXT — Micro Therapeutics, Inc.
- NXT — Micro Therapeutics, Inc.
- NXT — 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 9ddae18e-c339-4eba-839c-99a13415c7c8 37 fields · synced Jun 8, 2026