Identity
- Trade Name
- Embotrap FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- EMBOTRAP II 5X33 REVASCULARISATION. DEVICE FDA UDI
- Model / Reference
- ET009533 FDA UDI
- Description
- EMBOTRAP II 5X33 REVASCULARISATION. DEVICE FDA UDI
Identifiers
- Catalog Number
- ET009533 FDA UDI
- Primary DI / UDI-DI
- 10886704081326 FDA UDI
- 510(k) Number
- K173452 FDA UDI
- FDA Product Code
- NRY FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thrombectomy suction catheter
Embotrap by Neuravi, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thrombectomy suction catheter.
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- Indigo System — PENUMBRA, INC. · Class II
- Penumbra System — PENUMBRA, INC. · Class II
- Trevo — Stryker Corp.
- Penumbra System — PENUMBRA, INC. · Class II
- Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
Cleared under the same submission
K173452 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
- Neuravi, Ltd.
Sources (1)
- FDA UDI e4302f8e-7939-42d2-80bf-1879b9aa330b 35 fields · synced Jun 8, 2026