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

GUDID 04540778139602

The Xpress-Way RX Extraction Catheter is indicated for thrombi the removal of fresh, soft emboli and from vessels in the coronary and peripheral vascu

KANEKA CORPORATION

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter
Primary Device ID04540778139602
NIH Device Record Key115eac36-fff2-44e9-90dd-71cb3ba4c5d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameXPRESS-WAY RX Catheter (6F LD-Version)
Version Model NumberT2R6SA4L
Company DUNS690535406
Company NameKANEKA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com
Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com
Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com
Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com
Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com
Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com
Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com
Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com
Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com
Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com
Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com
Phone1-800-526-3521
Emailtakuji.hasegawa@kaneka.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.

Device Identifiers

Device Issuing AgencyDevice ID
GS104540778139602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXECatheter, Embolectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-17

Devices Manufactured by KANEKA CORPORATION

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04540778177550 - i-ED COIL2022-06-01 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
04540778177604 - i-ED COIL2022-06-01 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
04540778177611 - i-ED COIL2022-06-01 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
04540778176430 - i-ED COIL2020-07-08 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.

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