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Metacross OTW
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BD-L50150SWModel Kaneka PTA Balloon Dilatation Catheters
Identity
- Trade Name
- Metacross OTW EUDAMEDFDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- Metacross OTW EUDAMEDMETACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm). FDA UDI
- Model / Reference
- Kaneka PTA Balloon Dilatation Catheters EUDAMEDBD-L50150SW EUDAMEDFDA UDI
- Description
- METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm). FDA UDI
Identifiers
- Catalog Number
- BD-L50150SW FDA UDI
- Primary DI / UDI-DI
- 04540778155138 EUDAMEDFDA UDI
- Basic UDI-DI
- 4993478KNK0013Q EUDAMEDB-04540778155138 EUDAMED
- 510(k) Number
- K152080 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
- Germany 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
Metacross OTW by KANEKA Corporation — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 4993478KNK0013Q | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4993478KNK0013Q | 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 (3)
- EUDAMED d4678f24-93c2-47a4-817c-037a7506e39d 61 fields · synced Jul 9, 2026
- EUDAMED cc23594c-ca20-4d22-8000-bc30f45d7452 61 fields · synced May 19, 2026
- FDA UDI f01e13c8-a597-419a-873f-2c572d9fdbf7 38 fields · synced May 29, 2026