Identity
- Trade Name
- XPRESS-WAY RX FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system. The Xpress-Way RX is not intended for use in the cerebral vasculature. FDA UDI
- Model / Reference
- T2R6SA4A FDA UDI
- Description
- The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system. The Xpress-Way RX is not intended for use in the cerebral vasculature. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540778133976 FDA UDI
- 510(k) Number
- K101839 FDA UDI
- FDA Product Code
- DXE FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Thrombectomy suction catheter
Xpress-Way Rx by Kaneka Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Thrombectomy suction catheter.
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- Trevo — Stryker Corp.
- Penumbra System — PENUMBRA, INC. · Class II
- Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
Cleared under the same submission
K101839 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kaneka Corp.
Sources (1)
- FDA UDI 8c7d7d49-fcc6-4551-acbe-4b511310f65c 37 fields · synced May 30, 2026