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510(k) Data Aggregation
K Number
K120781Device Name
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
Manufacturer
FUJI SYSTEMS CORP.
Date Cleared
2012-08-09
(147 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
FUJI SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 Description
The CELLO Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with two radiopaque markers on both the distal and proximal ends of the balloon and a bifurcated luer hub on the proximal end. A compliant silicone balloon is mounted on the distal end. Balloon Guide Catheter dimensions and recommended inflation volumes are indicated on the product label. Each catheter is supplied with an appropriately-size Dilator.
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K Number
K051522Device Name
SILBRONCHO DOUBLE LUMEN TUBE
Manufacturer
FUJI SYSTEMS CORP.
Date Cleared
2005-08-17
(70 days)
Product Code
CBI
Regulation Number
868.5740Why did this record match?
Applicant Name (Manufacturer) :
FUJI SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silbroncho® is used to isolate the left or the right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Device Description
The Silbroncho® double lumen tube is made of silicone and is available in sizes 33 to 39 French. They are designed as a double lumen tube with 2 cuffs and separate 15 mm connectors for isolating and ventilating one lung during surgical procedures.
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