FDA.reportPublic FDA data

Fogarty

Primary DI
00690103205213
Brand
Fogarty
Company
Edwards Lifesciences LLC
Model
120804FP
Catalog number
120804FP
Device description
FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 80CM
Published
2020-09-15
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXECatheter, Embolectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193379000Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeEdwards Lifesciences, LLC2020-06-12DXE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50690103205218PackageGS15In Commercial Distribution
00690103205213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010320521850690103205218
00690103205213006901032052136901032052130690103205213

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103221664PASCAL Ace with Capture Clarity Valve Repair System30000ACEMR30000ACEMRA2026-09-24
00690103222388PASCAL Precision20000GS20000GSLA2026-09-24
00690103219500Edwards Reusable Rail10500RL10500RL2025-07-09
00690103205084FOGARTY120403FP120403FP2020-09-15
00690103218602SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
00690103218626SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
00690103218633SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103000245SWAN-GANZ TRUE SIZE096F6096F6P2016-09-03
00690103000269SWAN-GANZ110F5110F52016-09-03
00690103000276SWAN-GANZ TRUE SIZE111F7111F7P2016-09-03
00690103000313SWAN-GANZ TRUE SIZE114F7114F7P2016-09-03
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06

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
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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