Identity
- Trade Name
- NC Euphora™ FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- BALLOON NCEUP5012X NCEUPHORA RX US FDA UDI
- Model / Reference
- NCEUP5012X FDA UDI
- Description
- BALLOON NCEUP5012X NCEUPHORA RX US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169396104 FDA UDI
- 510(k) Number
- K141090 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 12.0 Millimeter FDA UDIOuter Diameter — 5.0 Millimeter FDA UDI
Category: Coronary angioplasty balloon catheter, basic
A comprehensive guide to the NC Euphora balloon catheter, including its features, use in coronary angioplasty, and regulatory information.
Similar devices
Also classified as Coronary angioplasty balloon catheter, basic.
- REBEL™ — Boston Scientific · Class III
- Pantera Pro — Biotronik, Inc. · Class II
- Emerge™ — Boston Scientific · Class II
- AngioSculpt® PTCA Scoring Balloon Catheter — Angioscore, Inc. · Class III
- SC HONKYTONK — Sino Medical Sciences Technology Inc. · Class II
- OTW TAKERU — Kaneka Corp. · Class II
- NC ROCKSTAR — Sino Medical Sciences Technology Inc. · Class II
- Emerge™ — Boston Scientific · Class II
Cleared under the same submission
K141090 also covers:
- NC Euphora™ — MEDTRONIC, INC.
- NC Euphora™ — MEDTRONIC, INC.
- NC Euphora™ — MEDTRONIC, INC.
- NC Euphora™ — MEDTRONIC, INC.
- NC Euphora™ — MEDTRONIC, INC.
- NC Euphora™ — MEDTRONIC, INC.
- NC Euphora™ — MEDTRONIC, INC.
- NC Euphora™ — MEDTRONIC, INC.
- NC Euphora™ — MEDTRONIC, INC.
- NC Euphora™ — MEDTRONIC, INC.
- NC Euphora™ — MEDTRONIC, INC.
- NC Euphora™ — MEDTRONIC, 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
- Medtronic, Inc.
Sources (1)
- FDA UDI f9e2e057-028e-452e-be9c-aa84714e1417 36 fields · synced Jul 29, 2026