FDA.reportPublic FDA data

LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)

Primary DI
00850076916008
Brand
LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)
Company
LUCAS MEDICAL INC
Model
NL2EMB40
Device description
EDWARDS (PLD)
Published
2026-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00850076916008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850076916008008500769160088500769160080850076916008

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy balloon catheterA 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850076916015LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL2EMB602026-09-18
00850076916022LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL2EMB802026-09-18
00850076916039LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL3EMB402026-09-18
00850076916046LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL3EMB802026-09-18
00850076916053LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL4EMB402026-09-18
00850076916060LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL4EMB802026-09-18
00850076916077LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL5EMB402026-09-18
00850076916084LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL5EMB802026-09-18
00850076916091LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL6EMB402026-09-18
00850076916107LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL6EMB802026-09-18
00850076916114LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL7EMB402026-09-18
00850076916121LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL7EMB802026-09-18
00850076916855LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)NL4EMB1002026-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076916015LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916022LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916039LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916046LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916053LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916060LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916077LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916084LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916091LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916107LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916114LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916121LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916855LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00885403530374Fogarty CorkscrewBecton, Dickinson And CompanyDXE2026-09-04
00885403530381Fogarty CorkscrewBecton, Dickinson And CompanyDXE2026-09-04
00885403530398Fogarty CorkscrewBecton, Dickinson And CompanyDXE2026-09-04
00884450466995Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-27
00884450466988Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-25
00884450467008Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-25
00885403530534FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyDXE2026-08-14
00885403530404FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530411FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530428FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530442FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530466FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyDXE2026-07-31