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Sign in to claim this brandWhat Kaneka Corp. makes
Kaneka Corp. manufactures a range of interventional and vascular devices, including coronary and peripheral angioplasty balloon catheters for clearing blocked arteries, embolization coils for treating vascular abnormalities, and thrombectomy suction catheters for removing clots. Their portfolio also includes lacrimal tubes for drainage of the tear duct, electronic vascular implant detachers for retrieving devices post-deployment, and haemoperfusion absorption columns for filtering toxins from blood.
The company’s devices are classified under FDA’s Class II, Unclassified, and Class U categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Kaneka Corp. is based in the United States, adhering to regulatory requirements for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Kaneka Corp. manufacture?
Kaneka Corp. specializes in interventional and vascular medical devices. Their portfolio includes coronary and peripheral angioplasty balloon catheters, which are used to clear blocked arteries; embolization coils (both neurovascular and non-neurovascular) for treating vascular abnormalities; thrombectomy suction catheters for clot removal; lacrimal tubes for tear duct drainage; electronic vascular implant detachers for retrieving deployed devices; and haemoperfusion absorption columns for filtering toxins from blood.
Where is Kaneka Corp. based, and how does this affect its regulatory compliance?
Kaneka Corp. is based in the United States, which means its devices must comply with FDA regulations. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, demonstrating adherence to U.S. regulatory requirements for medical device identification and tracking.
Which regulatory registries list Kaneka Corp.’s devices?
Kaneka Corp.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency and traceability of medical devices by assigning a standardized identifier to each product, helping healthcare providers and regulators track and monitor them effectively.
How are Kaneka Corp.’s devices classified under FDA regulations?
Kaneka Corp.’s devices fall under three FDA classification categories: Class II (moderate risk, requiring special controls beyond general controls), Unclassified (new or low-risk devices awaiting classification), and Class U (unclassified devices that may later be reclassified). Classification determines the regulatory pathway and scrutiny each device undergoes before market authorization.
What is the purpose of devices like the RX TAKERU or CROSSTELLA RX in Kaneka Corp.’s portfolio?
The RX TAKERU and CROSSTELLA RX are examples of vascular implant detachers, which are electronic, single-use devices designed to retrieve implanted vascular stents or other devices *after* they have been deployed in a patient’s blood vessel. These tools help address complications by allowing precise removal of the implanted component when necessary.
AI-generated from registry data and not verified by a human reviewer.
Information
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Catalogue (305)
Page 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| i-ED COIL | 392-0620 | FDA UDI | Class II | Active |
| Otw Takeru | DC-PY3012UA2 | FDA UDI | Class II | Active |
| Crosstella Rx | BD-F50060ER | FDA UDI | Class II | Active |
| Rx Nc Takeru | DC-RZ3012UA2 | FDA UDI | Class II | Active |
| Rx Takeru | DC-RY1515UA1 | FDA UDI | Class II | Active |
| i-ED COIL | 393-030520 | FDA UDI | Class II | Active |
| Rx Nc Takeru | DC-RZ4521UA2 | FDA UDI | Class II | Active |
| i-ED COIL | 390-0204 | FDA UDI | Class II | Active |
| Rx Takeru | DC-RY5008UA2 | FDA UDI | Class II | Active |
| Crosstella Rx | BD-F60200ER | FDA UDI | Class II | Active |
| i-ED COIL | 392-1250 | FDA UDI | Class II | Active |
| Rx Takeru | DC-RY4508UA2 | FDA UDI | Class II | Active |
| Rx Takeru | DC-RY2515UA2 | FDA UDI | Class II | Active |
| Crosstella Rx | BD-F50080ER | FDA UDI | Class II | Active |
| i-ED COIL | 390-01H3 | FDA UDI | Class II | Active |
| Otw Takeru | DC-PY2520UA2 | FDA UDI | Class II | Active |
| Rx Nc Takeru | DC-RZ3208UA2 | FDA UDI | Class II | Active |
| Otw Takeru | DC-PY1520UA1 | FDA UDI | Class II | Active |
| Otw Takeru | DC-PY3510UA2 | FDA UDI | Class II | Active |
| Rx Takeru | DC-RY1510UA1 | FDA UDI | Class II | Active |
| Rx Nc Takeru | DC-RZ4508UA2 | FDA UDI | Class II | Active |
| Rx Takeru | DC-RY2530UA2 | FDA UDI | Class II | Active |
| XPRESS-WAY RX Catheter (6F LD-Version) | T2R6SA4L | FDA UDI | Class II | Active |
| Otw Takeru | DC-PY3520UA2 | FDA UDI | Class II | Active |
| i-ED COIL | 392-1040 | FDA UDI | Class II | Active |
| Crosstella Rx | BD-F50040ER | FDA UDI | Class II | Active |
| Crosstella Rx | BD-F40120ER | FDA UDI | Class II | Active |
| Otw Takeru | DC-PY1510UA1 | FDA UDI | Class II | Active |
| Crosstella Rx | BD-F40040ER | FDA UDI | Class II | Active |
| Rx Nc Takeru | DC-RZ3521UA2 | FDA UDI | Class II | Active |
| Otw Takeru | DC-PY2030UA2 | FDA UDI | Class II | Active |
| Rx Nc Takeru | DC-RZ3506UA2 | FDA UDI | Class II | Active |
| i-ED COIL | 392-0408 | FDA UDI | Class II | Active |
| Otw Takeru | DC-PY2212UA2 | FDA UDI | Class II | Active |
| i-ED COIL | 392-0306 | FDA UDI | Class II | Active |
| Otw Takeru | DC-PY3512UA2 | FDA UDI | Class II | Active |
| Liposorber | LA-15 | FDA UDI | Unclassified | Active |
| Otw Takeru | DC-PY4020UA2 | FDA UDI | Class II | Active |
| Crosstella Rx | BD-F60020ER | FDA UDI | Class II | Active |
| Crosstella Rx | BD-F20100ER | FDA UDI | Class II | Active |
| Rx Nc Takeru | DC-RZ4021UA2 | FDA UDI | Class II | Active |
| Crosstella Rx | BD-F50020ER | FDA UDI | Class II | Active |
| Otw Takeru | DC-PY4508UA2 | FDA UDI | Class II | Active |
| Crosstella Rx | BD-F25020ER | FDA UDI | Class II | Active |
| Crosstella Rx | BD-F20020ER | FDA UDI | Class II | Active |
| Rx Takeru | DC-RY2715UA2 | FDA UDI | Class II | Active |
| Lixelle | S-25 | FDA UDI | Unclassified | Unknown |
| Rx Takeru | DC-RY4012UA2 | FDA UDI | Class II | Active |
| Rx Nc Takeru | DC-RZ3030UA2 | FDA UDI | Class II | Active |
| Otw Takeru | DC-PY3720UA2 | FDA UDI | Class II | Active |
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