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Crosstella OTW
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BD-F40060MWModel Kaneka PTA Balloon Dilatation Catheters
Identity
- Trade Name
- Crosstella OTW EUDAMEDFDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- Crosstella OTW EUDAMEDCROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm). FDA UDI
- Model / Reference
- BD-F40060MW EUDAMEDFDA UDIKaneka PTA Balloon Dilatation Catheters EUDAMED
- Description
- CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm). FDA UDI
Identifiers
- Catalog Number
- BD-F40060MW FDA UDI
- Primary DI / UDI-DI
- 04540778160750 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540778160750 EUDAMED4993478KNK0013Q EUDAMED
- 510(k) Number
- K160004 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
Crosstella OTW by KANEKA Corporation — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04540778160750 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04540778160750 | 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 29af447d-affa-44ec-afaa-8f3a4aa683a0 61 fields · synced Jul 8, 2026
- EUDAMED ab420968-cfb2-43f7-bdc6-52a5a57bddd0 61 fields · synced May 19, 2026
- FDA UDI 372ce7c1-a1de-45ad-8e12-a855cce3e918 38 fields · synced May 30, 2026