Identity
- Trade Name
- ZelanteDVT™ ClotHunter™ FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- Helical Rotation Device FDA UDI
- Model / Reference
- 114690-001 FDA UDI
- Description
- Helical Rotation Device FDA UDI
Identifiers
- Catalog Number
- 114690-001 FDA UDI
- Primary DI / UDI-DI
- 08714729968740 FDA UDI
- FDA Product Code
- KRA FDA UDIQEW FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1210 FDA UDI870.5150 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
No
FDA UDI
Category: Thrombectomy suction catheter
ZelanteDVT™ ClotHunter™ by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thrombectomy suction catheter.
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- Pounce ™ Thrombectomy — Surmodics, 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
- Boston Scientific
Sources (1)
- FDA UDI 5e4e6377-ecba-4b97-99f1-5298fa92f4ad 35 fields · synced May 30, 2026