KANEKA CORPORATION

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Device Description : The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli an 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.

Device Class : 2

Duns Number: 690535406

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

Device Description : The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli an 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.

Device Class : 2

Duns Number: 690535406

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

Device Description : The Xpress-Way RX Extraction Catheter is indicated for thrombi the removal of fr 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.

Device Class : 2

Duns Number: 690535406

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The LACRIFLOW is indicated in treatments of epiphora in-patients 12 months and o The LACRIFLOW is indicated in treatments of epiphora in-patients 12 months and older, in cases of:- Canalicular pathologies (stenosis, obstruction, lacerations),- During Dacryocystorhinostomy (conventional or laser),- Congenital nasolacrimal duct obstruction.

Device Class :

Duns Number: 690535406

Premarket Exempt : No

Product Code : OKS

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The LACRIFLOW is indicated in treatments of epiphora in-patients 12 months and o The LACRIFLOW is indicated in treatments of epiphora in-patients 12 months and older, in cases of:- Canalicular pathologies (stenosis, obstruction, lacerations),- During Dacryocystorhinostomy (conventional or laser),- Congenital nasolacrimal duct obstruction.

Device Class :

Duns Number: 690535406

Premarket Exempt : No

Product Code : OKS

Prescription Use : Yes

Device Count : 1

- Catalog Number : BD-L30020MR

Device Description : METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).

Device Class : 2

Duns Number: 690535406

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

- Catalog Number : BD-L40020MR

Device Description : METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).

Device Class : 2

Duns Number: 690535406

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

- Catalog Number : BD-L50020MR

Device Description : METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).

Device Class : 2

Duns Number: 690535406

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

- Catalog Number : BD-L60020MR

Device Description : METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).

Device Class : 2

Duns Number: 690535406

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

- Catalog Number : BD-L70020MR

Device Description : METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).

Device Class : 2

Duns Number: 690535406

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1