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Vela RX PTA Balloon Dilatation Catheter
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 21510140
Identity
- Device Name
- Vela RX PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 21510140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970226523208 EUDAMED
- Basic UDI-DI
- 697022652105FN EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Estonia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Peripheral angioplasty balloon catheter, basic
Vela RX PTA Balloon Dilatation Catheter by Curatia Medical Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
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- Simpass — Simeks Tibbi Urunler San. ve Tic LTD STI · Class IIa
- Metacross OTW — KANEKA Corporation · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171290 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697022652105FN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Curatia Medical Limited
- EUDAMED SRN
- CN-MF-000015976
- Authorised Representative
- MedNet EC-REP III GmbH DE-AR-000011191
Sources (2)
- EUDAMED ed3cde7b-1663-4f54-ba76-f853b7f083f3 61 fields · synced Oct 7, 2026
- FDA 510(k) K171290 1 fields · synced May 18, 2026