Identity
- Trade Name
- VesPenetrator® FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Model / Reference
- PD17514 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934184003073 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
VesPenetrator® by Dongguan TT Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230374 also covers:
- 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.
- VesTraveler® — Dongguan TT Medical, 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
- Dongguan TT Medical, Inc.
Sources (1)
- FDA UDI 0d5d6f10-df84-4713-b6b3-b454d427dfc1 33 fields · synced May 30, 2026