Identity
- Trade Name
- VesTraveler® FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Model / Reference
- SD20010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934184002151 FDA UDI
- 510(k) Number
- K230374 FDA UDI
- FDA Product Code
- LOX FDA UDI
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5100 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
No
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: Coronary angioplasty balloon catheter, basic
VesTraveler® by Dongguan TT Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, basic.
- REBEL™ — Boston Scientific · Class III
- SPRINTER® LEGEND — MEDTRONIC, INC. · Class II
- NC STORMER® OTW — MEDTRONIC, INC. · Class II
- Pantera Pro — Biotronik, Inc. · Class II
- SPRINTER LEGEND — MEDTRONIC, INC. · Class II
- SPRINTER® LEGEND — MEDTRONIC, INC. · Class II
- SPRINTER LEGEND — MEDTRONIC, INC. · Class II
- Emerge™ — Boston Scientific · Class II
Cleared under the same submission
K230374 also covers:
- VesPenetrator® — Dongguan TT Medical, Inc.
- VesPenetrator® — Dongguan TT Medical, Inc.
- VesPenetrator® — Dongguan TT Medical, Inc.
- VesPenetrator® — Dongguan TT Medical, Inc.
- VesTraveler® — Dongguan TT Medical, Inc.
- VesTraveler® — Dongguan TT Medical, Inc.
- VesTraveler® — Dongguan TT Medical, Inc.
- VesTraveler® — Dongguan TT Medical, Inc.
- VesTraveler® — Dongguan TT Medical, Inc.
- VesTraveler® — Dongguan TT Medical, Inc.
- VesTraveler® — Dongguan TT Medical, Inc.
- VesTraveler® — Dongguan TT Medical, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dongguan TT Medical, Inc.
Sources (2)
- FDA UDI abc4802a-fa89-4a2a-a9a2-93a3da6ba854 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026