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Crosperio RX
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref BD-B30020MRModel Kaneka PTA Balloon Dilatation Catheters
Identity
- Trade Name
- Crosperio RX EUDAMED
- Device Name
- Crosperio RX EUDAMED
- Model / Reference
- Kaneka PTA Balloon Dilatation Catheters EUDAMEDBD-B30020MR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540778183797 EUDAMED
- Basic UDI-DI
- 4993478KNK0013Q EUDAMEDB-04540778183797 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Crosperio RX by KANEKA Corporation — Class IIa — FDA_510K, MDR, MDD — 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
- Advocate™ — Merit Medical Systems, Inc. · Class II
- 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
- Armada — Abbott Vascular · Class II
- RapidCross — Covidien LP · Class II
- Chocolate PTA Balloon Catheter — TRIREME MEDICAL, LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152887 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4993478KNK0013Q | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 4993478KNK0013Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- KANEKA Corporation
- EUDAMED SRN
- JP-MF-000022143
- Authorised Representative
- Kaneka Medical Europe N.V. BE-AR-000010091
Sources (3)
- EUDAMED 7e6c8191-df7d-4437-afb3-24f240a3757d 61 fields · synced Jul 8, 2026
- EUDAMED 17deacb7-9bf1-4d2d-b8ba-3450cf1357d1 61 fields · synced May 17, 2026
- FDA 510(k) K152887 1 fields · synced May 18, 2026