Crosstella OTW
EUDAMEDFDA UDIClass IIa (EU MDR)
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-F30120LW 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-F30120LW FDA UDI
- Primary DI / UDI-DI
- 04540778162051 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540778162051 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Peripheral angioplasty balloon catheter, basic
Crosstella OTW by KANEKA Corporation — Class IIa — MDR, MDD, 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
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04540778162051 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04540778162051 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KANEKA Corporation
- EUDAMED SRN
- JP-MF-000022143
- Authorised Representative
- Kaneka Medical Europe N.V. BE-AR-000010091
Sources (3)
- EUDAMED 6751ad38-393e-41e4-82af-47151c0d59b6 61 fields · synced Jul 8, 2026
- EUDAMED 5596b784-5419-4144-a593-8ee317c1ecc6 61 fields · synced May 19, 2026
- FDA UDI 6e7148fa-306a-43cd-83e2-9661902babdd 38 fields · synced May 30, 2026