FDA.report

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

Related Records

Product Codes

CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions

SubmissionSupplement
K160084000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K160084000Swan Ganz CathetersEdwards Lifesciences, LLC2016-05-03DYG

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50690103218607PackageGS15In Commercial Distribution
00690103218602PrimaryGS10

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL, DRY PLACE.

Sterilization Methods

Method

Contacts

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

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00690103221329Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL23A9631PL23A2026-02-17
00690103221336Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL26A9631PL26A2026-02-17
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00690103019353AORTIC TRUE-SIZE OBTURATOR 19MM1161116119MM2026-02-13
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00690103019377AORTIC TRUE-SIZE OBTURATOR 23MM1161116123MM2026-02-13
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00690103019391AORTIC TRUE-SIZE OBTURATOR 27MM1161116127MM2026-02-13
00690103019407AORTIC TRUE-SIZE OBTURATOR 29MM1161116129MM2026-02-13
00690103019414AORTIC TRUE-SIZE OBTURATOR 31MM1161116131MM2026-02-13
00690103019278HEART VALVE SIZER ACCESSORY1127112723MM2026-02-11
00690103019285HEART VALVE SIZER ACCESSORY1127112725MM2026-02-11
00690103019292HEART VALVE SIZER ACCESSORY1127112727MM2026-02-11

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