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Crosperio OTW
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BD-B20020LWModel Kaneka PTA Balloon Dilatation CathetersRef BD-B35020MWRef BD-B25020MWRef BD-B25020LWRef BD-B15080SWRef BD-B20020SWRef BD-B30020MW
Identity
- Trade Name
- Crosperio OTW EUDAMEDFDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm). FDA UDI
- Model / Reference
- Kaneka PTA Balloon Dilatation Catheters EUDAMEDBD-B20020LW EUDAMEDBD-B35020MW EUDAMEDBD-B25020MW EUDAMEDBD-B25020LW EUDAMEDBD-B15080SW EUDAMEDFDA UDIBD-B20020SW EUDAMEDBD-B30020MW EUDAMED
- Description
- CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm). FDA UDI
Identifiers
- Catalog Number
- BD-B15080SW FDA UDI
- Primary DI / UDI-DI
- 04540778183971 EUDAMED04540778183957 EUDAMED04540778183933 EUDAMED04540778183988 EUDAMED04540778163676 EUDAMEDFDA UDI04540778183872 EUDAMED04540778183940 EUDAMED
- Basic UDI-DI
- 4993478KNK0013Q EUDAMED
- 510(k) Number
- K160013 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
Category: Peripheral angioplasty balloon catheter, basic
Crosperio OTW by KANEKA Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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- 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/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (8)
- EUDAMED 39544fbf-3436-4e1d-872b-dc186bf07f70 61 fields · synced Jul 25, 2026
- EUDAMED 0567ed5e-4f91-4eb8-98a7-3549bf936081 61 fields · synced May 17, 2026
- EUDAMED a8b711a9-e52f-4408-8527-9d683678be4a 61 fields · synced May 18, 2026
- EUDAMED 50158e8a-2347-41c4-b635-48748f2f3cde 61 fields · synced May 18, 2026
- EUDAMED 7aedafb4-ef41-4597-922f-e64563c46397 61 fields · synced May 18, 2026
- EUDAMED 509cbac6-5fe8-42e2-8743-58412dafc67b 61 fields · synced May 18, 2026
- EUDAMED a5f9584a-02ad-48bd-a979-974f20512502 61 fields · synced May 19, 2026
- FDA UDI f883f1d7-a770-42af-bafe-27bef21f84f0 38 fields · synced May 29, 2026