FDA.reportPublic FDA data

LMI ARTERIAL EMBOLECTOMY CATHETER

Primary DI
B3804FEMB1000
Brand
LMI ARTERIAL EMBOLECTOMY CATHETER
Company
LUCAS MEDICAL INC
Model
4FEMB100
Published
2016-09-02
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
DXECatheter, Embolectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954760000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954760000LMI ARTERIAL EMBOLECTOMY CATHETERLucas Medical, Inc.1996-04-11DXE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3804FEMB1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy balloon catheterA sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through distension of a balloon intended to dilate the stenosis. It is a balloon catheter that may include valves for the injection of contrast media/thrombolytic agents and/or an embolectomy coil for mechanical removal of the obstruction. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483504455Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504486Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504516Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
10841156110512PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
20841156110519PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
00850291007697Large Bore 60 cc SyringeInari Medical, Inc.DXE2024-12-20
00763000762353Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762407Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762414Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762421Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762438Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
08886483507524Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2023-10-31
00860010378007ICHORICHOR VASCULAR, INC.DXE2023-10-13
10801902196603ARROWTELEFLEX INCORPORATEDDXE2022-11-15
20801902196600ARROWTELEFLEX INCORPORATEDDXE2022-11-15
10801902194043ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194050ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194067ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194074ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194081ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194098ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194104ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902196610ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194040ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194057ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194064ARROWTELEFLEX INCORPORATEDDXE2022-11-08