FDA.reportPublic FDA data

LMI BILUMEN BILIARY CATHETER DISTAL

Primary DI
B3804FBBIR440D0
Brand
LMI BILUMEN BILIARY CATHETER DISTAL
Company
LUCAS MEDICAL INC
Model
4FBBIR440D
Published
2019-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGEStents, Drains And Dilators For The Biliary Ducts

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955126000LMI BILIARY CATHETERLucas Medical, Inc.1996-05-10FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3804FBBIR440D0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainage catheterA flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
878198993
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3803FOCC230LMI OCCLUSION CATHETER3FOCC232016-09-02
B3803FOCC400LMI OCCLUSION CATHETER3FOCC402016-09-02
B3804FIRR040D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTOMY CATHETER4FIRR040D2016-09-06
B3804FIRR040P0LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLECTOMY CATHETER4FIRR040P2016-09-06
B3804FIRR080D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTOMY CATHETER4FIRR080D2016-09-06
B3804FIRR080P0LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLECTOMY CATHETER4FIRR080P2016-09-06
B3804FOCC230LMI OCCLUSION CATHETER4FOCC232016-09-02
B3804FOCC400LMI OCCLUSION CATHETER4FOCC402016-09-02
B3805FIRR040D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTOMY CATHETER5FIRR040D2016-09-06
B3805FIRR040P0LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLECTOMY CATHETER5FIRR040P2016-09-06
B3805FIRR080D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTOMY CATHETER5FIRR080D2016-09-06
B3805FIRR080P0LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLECTOMY CATHETER5FIRR080P2016-09-06
B3805FOCC230LMI OCCLUSION CATHETER5FOCC232016-09-02
B3805FOCC400LMI OCCLUSION CATHETER5FOCC402016-09-02
B3806FIRR040D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTOMY CATHETER6FIRR040D2016-09-06
B3806FIRR040P0LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLECTOMY CATHETER6FIRR040P2016-09-06
B3806FIRR080D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTOMY CATHETER6FIRR080D2016-09-06
B3806FIRR080P0LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLECTOMY CATHETER6FIRR080P2016-09-06
B3806FOCC230LMI OCCLUSION CATHETER6FOCC232016-09-02
B3806FOCC400LMI OCCLUSION CATHETER6FOCC402016-09-02

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