Identity
- Trade Name
- SolitiareTM FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- STENT SFR2-6-30 V01 US FDA UDI
- Model / Reference
- SFR2-6-30 FDA UDI
- Description
- STENT SFR2-6-30 V01 US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847536020733 FDA UDI
- 510(k) Number
- K123378 FDA UDI
- FDA Product Code
- NRY FDA UDIPOL FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI882.5600 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
SolitiareTM by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K123378 also covers:
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 262001db-3b8a-438b-ae59-6d5683134ccf 37 fields · synced May 31, 2026