FDA.reportPublic FDA data

CELLO™, Balloon Guide Catheter

Primary DI
04544050120715
Brand
CELLO™, Balloon Guide Catheter
Company
FUJI SYSTEMS CORPORATION
Model
1610560
Device description
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.
Published
2022-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120781000CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTHFuji Systems Corp.2012-08-09DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14544050120712PackageGS11In Commercial Distribution
04544050093446PreviousGS10
04544050120715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454405012071214544050120712
04544050093446045440500934464544050093446
04544050120715045440501207154544050120715

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA 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 malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Inner Diameter1.3Millimeter
Device Size Text, specify0
Outer Diameter1.9Millimeter
Shaft Length950Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry, dark place
Storage Environment Temperature0 Degrees Celsius54 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
715919973
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04544050121057CELLO II Balloon Guide Catheter, 8F 90cm16509082026-05-25
04544050123815UNIVENT TUBE (TCB TYPE)I.D. 8.0MM12029332024-01-31
04544050123839UNIVENT TUBE (TCB TYPE)I.D. 6.0MM12029272024-01-31
04544050123846UNIVENT TUBE (TCB TYPE)I.D. 6.5MM12029282024-01-31
04544050123853UNIVENT TUBE (TCB TYPE)I.D. 7.0MM12029302024-01-31
04544050123860UNIVENT TUBE (TCB TYPE)I.D. 7.5MM12029312024-01-31
04544050123877UNIVENT TUBE (TCB TYPE)I.D. 8.5MM12029352024-01-31
04544050123884UNIVENT TUBE (TCB TYPE)I.D. 9.0MM12029362024-01-31
04544050123891UNIVENT TUBE (TCB TYPE)I.D. 9.5MM12029372024-01-31
04544050123907UNIVENT TUBE (TCB TYPE)I.D. 10.0MM12029392024-01-31
14544050123812UNIVENT TUBE (TCB TYPE)I.D. 8.0MM12029332024-01-31
14544050123836UNIVENT TUBE (TCB TYPE)I.D. 6.0MM12029272024-01-31
14544050123843UNIVENT TUBE (TCB TYPE)I.D. 6.5MM12029282024-01-31
14544050123850UNIVENT TUBE (TCB TYPE)I.D. 7.0MM12029302024-01-31
14544050123867UNIVENT TUBE (TCB TYPE)I.D. 7.5MM12029312024-01-31
14544050123874UNIVENT TUBE (TCB TYPE)I.D. 8.5MM12029352024-01-31
14544050123881UNIVENT TUBE (TCB TYPE)I.D. 9.0MM12029362024-01-31
14544050123898UNIVENT TUBE (TCB TYPE)I.D. 9.5MM12029372024-01-31
14544050123904UNIVENT TUBE (TCB TYPE)I.D. 10.0MM12029392024-01-31
04544050120739CELLO™, Balloon Guide Catheter16105802022-01-18

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Primary DI, Brand, Company table
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