FDA.reportPublic FDA data

FOGARTY

Primary DI
00690103205121
Brand
FOGARTY
Company
Edwards Lifesciences LLC
Model
410236FP
Catalog number
410236FP
Device description
FOGARTY BILIARY BALLOON PROBE 6F 23CM
Published
2020-08-31
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
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGastroenterology, Urology2

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
50690103205126PackageGS15In Commercial Distribution
00690103205121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010320512650690103205126
00690103205121006901032051216901032051210690103205121

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainA flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). 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
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
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664900093NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664900208NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901137NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901441NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901458NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902578NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902653NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902660NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903247NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903254NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903261NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664907528NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910689NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910696NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910726NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910733NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911006NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911013NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911082NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911099NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06970057571027Stone Extraction BalloonJiangsu Vedkang Medical Science and Technology Co.,Ltd.GCA2026-04-14
06948318963102AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
06948318963119AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
04711182608309Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
04711182608316Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608306Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608313Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
06959664910702NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910719NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910740NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09