VexPander®
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- VexPander® EUDAMEDFDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- VexPander® Coronary Dilatation Balloon Catheters EUDAMED
- Model / Reference
- VexPander® Balloon Catheter Series EUDAMEDTT-PTCA-2NC-BR-EN EUDAMEDNC32514 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934184011184 EUDAMED06934184001864 FDA UDI
- Basic UDI-DI
- 069341840NCSW EUDAMED
- 510(k) Number
- K230374 FDA UDI
- FDA Product Code
- LOX FDA UDI
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5100 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Coronary angioplasty balloon catheter, basic
VexPander® 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
MDR
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 10a74210-b159-4b98-b0ac-24251b8ebc6c 33 fields · synced Oct 6, 2026
- EUDAMED 80e0fed3-c407-47d2-b37b-843389c8dc02 61 fields · synced Jul 26, 2026