Parafleet SC 018 PTA Balloon Dilatation Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Parafleet SC 014 EUDAMEDParafleet SC 018 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
- F14-035020-070 EUDAMEDrev 01 FDA UDI
Identifiers
- Catalog Number
- F14-035020-070 FDA UDI
- Primary DI / UDI-DI
- 06942265500564 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
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: Peripheral angioplasty balloon catheter, basic
Parafleet SC 018 PTA Balloon Dilatation Catheter by BrosMed Medical Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Advocate™ — Merit Medical Systems, Inc. · Class II
- Senri — KANEKA Corporation · Class IIa
- Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
- RapidCross — Covidien LP · Class II
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- BrosMed Medical Co., Ltd.
Sources (2)
- FDA UDI b61c6986-945d-48c4-afa1-837c21a47c5a 34 fields · synced Oct 5, 2026
- EUDAMED 6e2fad1b-9ca1-4d03-b9a5-b56f0ee4caf0 61 fields · synced Oct 5, 2026