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Metacross RX
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BD-L70150ERRef BD-LX2040ERModel Kaneka PTA Balloon Dilatation CathetersRef BD-L30020CR
Identity
- Trade Name
- Metacross RX EUDAMEDFDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- Metacross RX EUDAMEDMETACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm). FDA UDI
- Model / Reference
- BD-L70150ER EUDAMEDFDA UDIBD-LX2040ER EUDAMEDFDA UDIKaneka PTA Balloon Dilatation Catheters EUDAMEDBD-L30020CR EUDAMEDFDA UDI
- Description
- METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm). FDA UDI
Identifiers
- Catalog Number
- BD-L30020CR FDA UDIBD-L70150ER FDA UDIBD-LX2040ER FDA UDI
- Primary DI / UDI-DI
- 04540778154094 EUDAMEDFDA UDI04540778153479 EUDAMEDFDA UDI04540778152052 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540778154094 EUDAMEDB-04540778153479 EUDAMED4993478KNK0013Q EUDAMEDB-04540778152052 EUDAMED
- 510(k) Number
- K150865 FDA UDI
- FDA Product Code
- DQY 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
- Germany EUDAMEDBelgium 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peripheral angioplasty balloon catheter, basic
Metacross RX by KANEKA Corporation — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04540778154094 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-04540778154094 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- KANEKA Corporation
- EUDAMED SRN
- JP-MF-000022143
- Authorised Representative
- Kaneka Medical Europe N.V. BE-AR-000010091
Sources (11)
- EUDAMED a4db7557-d5de-4841-9c49-42101351ccb7 61 fields · synced Sep 30, 2026
- EUDAMED e2a1f8b7-cc6f-4417-8e4a-75633a256b97 61 fields · synced May 11, 2026
- EUDAMED b9a2d595-c287-4678-a62c-ff80758967bc 61 fields · synced May 16, 2026
- EUDAMED 92966c90-d7b8-4c4b-966d-6cd6f66bd18c 61 fields · synced May 17, 2026
- EUDAMED 92b67f89-ee50-488d-9498-cb41cb3e60ae 61 fields · synced May 19, 2026
- EUDAMED 44690dce-0fed-4f7e-948a-15fab6194680 61 fields · synced May 19, 2026
- FDA UDI 540d0168-c176-4465-ac64-7f69ea9e7bc5 38 fields · synced May 30, 2026
- FDA UDI 5a302c5c-0a17-4610-8d71-51c40e288cf0 38 fields · synced May 30, 2026
- FDA UDI 57fdef16-6397-4a12-9a3a-7522c690b39b 38 fields · synced May 30, 2026
- EUDAMED c528d91e-c0a8-49db-89e9-d09401539b02 61 fields · synced Sep 17, 2026
- EUDAMED eb80013f-62c8-4cd5-be8b-e8a3e3be94f3 61 fields · synced Sep 30, 2026