FDA.report

CELLO II Balloon Guide Catheter, 8F 90cm

Primary DI
04544050121057
Brand
CELLO II Balloon Guide Catheter, 8F 90cm
Company
FUJI SYSTEMS CORPORATION
Model
1650908
Device description
The CELLO II 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. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
Published
2026-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications

CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04544050121057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04544050121057045440501210574544050121057

GMDN Terms

TermDefinition
Intravascular occluding balloon catheter, image-guidedA non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Regulatory Flags

DUNS number
715919973
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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