FDA.reportPublic FDA data

FOGARTY

Primary DI
50690103205133
Brand
FOGARTY
Company
Edwards Lifesciences LLC
Model
410405FP
Catalog number
410405FP
Device description
FOGARTY BILIARY BALLOON PROBE 5F 40CM
Published
2020-08-31
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

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
50690103205133PackageGS15In Commercial Distribution
00690103205138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010320513350690103205133
00690103205138006901032051386901032051380690103205138

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainage catheterA flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction. 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
134139174
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06

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00690103205114FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00690103205121FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00690103205138FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205119FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205126FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00816349011696TaxiLake Region MedicalGCA2018-11-27
04711182607548Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2017-08-15
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