FDA.reportPublic FDA data

SWAN-GANZ TRUE SIZE

Primary DI
50690103218607
Brand
SWAN-GANZ TRUE SIZE
Company
Edwards Lifesciences LLC
Model
096F6
Catalog number
096F6P
Device description
TRUE SIZE THERMODILUTION CATHETER
Published
2026-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160084000Swan Ganz CathetersEdwards Lifesciences, LLC2016-05-03DYG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50690103218607PackageGS15In Commercial Distribution
00690103218602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010321860750690103218607
00690103218602006901032186026901032186020690103218602

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary artery balloon catheter, electricalA flexible tube with an inflatable balloon(s) and electrical component(s) [e.g., thermistor, fibreoptic bundle] at its distal tip designed to be introduced percutaneously into the venous system via a central vein, and advanced to the pulmonary artery, to measure/monitor haematological parameters [e.g., pulmonary arterial pressures (e.g., wedge), cardiac output, cardiac index, mixed venous oxygen saturation (SvO2)]; it might use thermal dilution techniques and in addition be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included]. 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
true
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
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
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156112035LANGSTONTELEFLEX INCORPORATEDDQO2026-06-26
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
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