FDA.reportPublic FDA data

20MM X 4CM X 130CM EDWARDS BALLOON CATHETER

Primary DI
00690103191813
Brand
20MM X 4CM X 130CM EDWARDS BALLOON CATHETER
Company
Edwards Lifesciences LLC
Model
9350BC20
Catalog number
9350BC20A
Device description
EDWARDS BALLOON CATHETER
Published
2015-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
OZTBalloon aortic valvuloplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty CatheterCardiovascular2
OZTBalloon Aortic ValvuloplastyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140241000
K153069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140241000EDWARDS TRANSFEMORAL BALLOON CATHETEREdwards Lifesciences, LLC2014-07-03OZT
K153069000Edwards Balloon CatheterEdwards Lifesciences2016-01-07OMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103191813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103191813006901031918136901031918130690103191813

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103222456AUTUS Size Adjustable ValveAUT001AUT0012026-10-30
00690103220636ESHEATH OPTIMA14000ES16A14000ES162025-10-09
00690103219784Edwards 23F Guide Sheath9880GS9880GSA2026-01-30
00690103219562Edwards EVOQUE Loading System9850LSB9850LSBUS2025-07-09
00690103219579Edwards EVOQUE Stabilizer9850SZUS9850SZUS2025-07-09
00690103220629ESHEATH OPTIMA INTRODUCER SET (14F)14000ES1414000ES142025-05-07
00690103217773Edwards EVOQUE Loading System9850LSAUS9850LSAUS2024-10-03
00690103217483EVOQUE9850PTUS9850PTUS2024-02-07
00690103217490EVOQUE9850LSUS9850LSUS2024-02-07
00690103217506EVOQUE9850DKUS9850DKUS2024-02-07
00690103217513EVOQUE9850SBUS9850SBUS2024-02-07
00690103217476EVOQUE9850BAUS9850BAUS2024-02-06
00690103215465Edwards eSheath+ Introducer set914ESP914ESPA2021-10-06
00690103215472Edwards eSheath+ Introducer set916ESP916ESPA2021-10-06
00690103182262EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T262015-09-24
00690103182279EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T282015-09-24
00690103182286EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T302015-09-24
00690103182293EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T322015-09-24
00690103182309EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T342015-09-24
00690103182316EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T362015-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G825CVPSI23251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI24251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI25251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI26251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI27251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI28251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI29251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
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06009698453819OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOZT2026-05-20
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