FDA.reportPublic FDA data

LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTOMY CATHETER

Primary DI
B3805FIRR080D0
Brand
LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTOMY CATHETER
Company
LUCAS MEDICAL INC
Model
5FIRR080D
Published
2016-09-06
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
MJNCatheter, Intravascular Occluding, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955499000LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETERLucas Medical, Inc.1996-02-28MJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3805FIRR080D0PrimaryHIBCC0

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.

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
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
B3807FIRR040D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTOMY CATHETER7FIRR040D2016-09-06

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Primary DI, Brand, Company table
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00850001105064Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2022-12-15
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