Identity
- Trade Name
- Solitaire™ Platinum FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- STENT SFR3-4-20-10 V06 ENHANCED FDA UDI
- Model / Reference
- SFR3-4-20-10 FDA UDI
- Description
- STENT SFR3-4-20-10 V06 ENHANCED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847536034754 FDA UDI
- 510(k) Number
- K181186 FDA UDI
- FDA Product Code
- POL FDA UDINRY FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5600 FDA UDI870.1250 FDA UDI
- Commercial Distribution
- 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
Category: Thrombectomy suction catheter
Solitaire™ Platinum by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thrombectomy suction catheter.
- Symphony™ ProHelix™ — IMPERATIVE CARE INC. · Class II
- Prodigy™ Catheter — IMPERATIVE CARE INC. · Class II
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- Indigo System — PENUMBRA, INC. · Class II
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- Trevo — Stryker Corp.
- Penumbra System — PENUMBRA, INC. · Class II
- Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
Cleared under the same submission
K181186 also covers:
- Solitaire ™ Platinum — Micro Therapeutics, Inc.
- Solitaire ™ Platinum — Micro Therapeutics, Inc.
- Solitaire ™ Platinum — Micro Therapeutics, Inc.
- Solitaire ™ Platinum — Micro Therapeutics, Inc.
- Solitaire ™ Platinum — Micro Therapeutics, Inc.
- Solitaire ™ Platinum — Micro Therapeutics, Inc.
- Solitaire™ Platinum — Micro Therapeutics, Inc.
- Solitaire™ Platinum — Micro Therapeutics, Inc.
- Solitaire™ Platinum — Micro Therapeutics, Inc.
- Solitaire™ Platinum — Micro Therapeutics, Inc.
- Solitaire™ Platinum — 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 8c6ee332-7275-402c-853e-b3fb5bf8d6c8 36 fields · synced May 29, 2026