FDA.reportPublic FDA data

Biosensors Embolectomy Catheter

Primary DI
68888893235006
Brand
Biosensors Embolectomy Catheter
Company
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model
EL1440 (VP CAP)
Catalog number
23-000004-02
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXECatheter, Embolectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
68888893235006PackageGS160In Commercial Distribution
08888893235004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
6888889323500668888893235006
08888893235004088888932350048888893235004

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark cool dry places

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+6562135777Sales_CCP@biosensors.com

Regulatory Flags#

DUNS number
595182247
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08886483507470Silicone Foley CatheterFC316SDC-0001-0132026-05-04
08886483507487Silicone Foley CatheterFC314SDC-0001-0142026-05-04
08886483507494Silicone Foley CatheterFC318SDC-0001-0152026-05-04
08886483551640Thermodilution Catheter and AccessoriesTD1755HD21-000153-502026-05-20
08886483551657Thermodilution Catheter and AccessoriesTD2755NDF21-000202-452026-05-20
08886483551664Safewedge(TM) Relief Valve DeviceSafetywedge21-000212-012026-05-20
08886483500174Thermodilution Catheter and AccessoriesTD2604NXF21-000009-582026-05-04
08886483500181Thermodilution Catheter and AccessoriesTD2604NDXF21-000009-592026-05-04
08886483500372Thermodilution Catheter and AccessoriesTD2504NXF21-000046-432026-05-04
08886483500389Thermodilution Catheter and AccessoriesTD2504NDXF21-000046-442026-05-04
08886483501508Thermodilution Catheter and AccessoriesTD2704NDF21-000201-162026-05-04
08886483501515Thermodilution Catheter and AccessoriesTD2704NCXF21-000201-172026-05-04
08886483501546Thermodilution Catheter and AccessoriesTD2755NX21-000202-002026-05-04
08886483501553Thermodilution Catheter and AccessoriesTD2755NDF21-000202-012026-05-04
08886483501577Thermodilution Catheter and AccessoriesTD2755NDX21-000202-032026-05-04
08886483501584Thermodilution Catheter and AccessoriesTD2755NDPXF21-000202-042026-05-04
08886483502390BIOTRANS™ Pressure Monitoring KitsBTR4812-322-000813-232026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsEXTENSION TUBING SET22-000895-962026-05-04
08886483503748ACCUTRANS Disposable Pressure Monitoring KitAT W/O IFU(BNS)22-000940-022026-05-04
08886483504455Embolectomy CatheterEL144023-000006-152026-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076916008LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
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