Identity
- Trade Name
- Biosensors Embolectomy Catheter FDA UDI
- Generic Name
- Thrombectomy balloon catheter FDA UDI
- Model / Reference
- EL1440 (VP CAP) FDA UDI
Identifiers
- Catalog Number
- 23-000004-02 FDA UDI
- Primary DI / UDI-DI
- 08886483504349 FDA UDI
- FDA Product Code
- DXE FDA UDI
- GMDN Term
- Thrombectomy balloon catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 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
Yes
FDA UDI
Category: Thrombectomy balloon catheter
Biosensors Embolectomy Catheter by Bioptimal International Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Thrombectomy balloon catheter.
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- LeMaitre Embolectomy Catheter — LeMaitre Vascular, Inc. · Class II
- Fogarty — Edwards Lifesciences LLC · Class II
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- LeMaitre Embolectomy Catheter — LeMaitre Vascular, Inc. · Class II
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
- Bioptimal International Pte. Ltd.
Sources (1)
- FDA UDI 47f283c2-e26b-4ca1-9ca4-34fa2ce56d51 35 fields · synced May 31, 2026