Identity
- Trade Name
- Syntel Silicone Thrombectomy Catheter FDA UDI
- Generic Name
- Thrombectomy balloon catheter FDA UDI
- Device Name
- Syntel Silicone Thrombectomy Catheter FDA UDI
- Model / Reference
- A4558 FDA UDI
- Description
- Syntel Silicone Thrombectomy Catheter FDA UDI
Identifiers
- Catalog Number
- A4558 FDA UDI
- Primary DI / UDI-DI
- 00840663109838 FDA UDI
- 510(k) Number
- K910372 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
Dimensions & Sizes
- Size
- Catheter Working Length — 80 Centimeter FDA UDICatheter Gauge — 5 French FDA UDITotal Volume — 1.50 Milliliter FDA UDI
Category: Thrombectomy balloon catheter
Syntel Silicone Thrombectomy Catheter by LeMaitre Vascular, Inc. — 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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Cleared under the same submission
K910372 also covers:
- Syntel Silicone Thrombectomy Catheter — LeMaitre Vascular, Inc.
- Syntel Silicone Thrombectomy Catheter — LeMaitre Vascular, Inc.
- Syntel Silicone Thrombectomy Catheter — LeMaitre Vascular, Inc.
- Syntel Silicone Thrombectomy Catheter — LeMaitre Vascular, Inc.
- Syntel Silicone Thrombectomy Catheter — LeMaitre Vascular, Inc.
- Syntel Silicone Thrombectomy Catheter — LeMaitre Vascular, 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
- LeMaitre Vascular, Inc.
Sources (1)
- FDA UDI e080ef09-1a7d-4d01-9586-9480535ce421 38 fields · synced Jun 9, 2026