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Parafleet SC 014 PTA Balloon Dilatation Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref F14-020060-200
Identity
- Trade Name
- Parafleet SC 014 EUDAMEDParafleet SC 014 PTA Balloon Dilatation Catheter FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- Polux Pro / Parafleet SC 014 PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- F14-020060-200 EUDAMEDrev 02 FDA UDI
Identifiers
- Catalog Number
- F14-020060-200 FDA UDI
- Primary DI / UDI-DI
- 06942265505958 EUDAMEDFDA UDI
- Basic UDI-DI
- 695848140063MF EUDAMED
- 510(k) Number
- K243704 FDA UDI
- FDA Product Code
- LIT FDA UDI
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Parafleet SC 014 PTA Balloon Dilatation Catheter by BrosMed Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
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
- BrosMed Medical Co., Ltd.
Sources (2)
- FDA UDI c4a2935f-3298-495c-83d5-a16908bb4d4d 34 fields · synced Oct 6, 2026
- EUDAMED b0dbb61e-6f2f-4e62-b5d3-a4ee8628b84b 61 fields · synced Sep 17, 2026