XPRESS-WAY RX Catheter (6F LD-Version)

FDA UDI

Class II (US FDA UDI)

by Kaneka Corp.

Identity

Trade Name: XPRESS-WAY RX Catheter (6F LD-Version) FDA UDI
Generic Name: Thrombectomy suction catheter FDA UDI
Device Name: The Xpress-Way RX Extraction Catheter is indicated for thrombi the removal of fresh, soft emboli and from vessels in the coronary and peripheral vasculature. The Xpress-Way RX Extraction Catheter is not intended for use in the cerebral vasculature. FDA UDI
Model / Reference: T2R6SA4L FDA UDI
Description: The Xpress-Way RX Extraction Catheter is indicated for thrombi the removal of fresh, soft emboli and from vessels in the coronary and peripheral vasculature. The Xpress-Way RX Extraction Catheter is not intended for use in the cerebral vasculature. FDA UDI

Identifiers

Primary DI / UDI-DI: 04540778139602 FDA UDI
510(k) Number: K121301 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Thrombectomy suction catheter

XPRESS-WAY RX Catheter (6F LD-Version) by Kaneka Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 115eac36-fff2-44e9-90dd-71cb3ba4c5d2 37 fields · synced May 30, 2026