FUJI SYSTEMS CORPORATION

Address:Shirakawa Plant,Nishi Shirakawa Gun Fukushima,JP

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Catheter, Percutaneous (DQY) (3)

Premarket Exempt

Clear

CELLO™, Balloon Guide Catheter - 04544050120722 Catalog Number :

Device Description : The CELLO Balloon Guide Catheter is indicated for use in facilitating the insert The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

Device Class : 2

Duns Number: 715919973

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

CELLO™, Balloon Guide Catheter - 04544050120739 Catalog Number :

Device Class : 2

Duns Number: 715919973

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

CELLO™, Balloon Guide Catheter - 04544050120746 Catalog Number :

Device Class : 2

Duns Number: 715919973

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

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