FDA.reportPublic FDA data

SWAN-GANZ

Primary DI
00885403521624
Brand
SWAN-GANZ
Company
Becton, Dickinson And Company
Model
D97130F5
Catalog number
D97130F5
Device description
SWAN-GANZ BIPOLAR PACING CATHETER
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYGCATHETER, FLOW DIRECTED
LDFELECTRODE, PACEMAKER, TEMPORARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2
LDFElectrode, Pacemaker, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233983000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233983000Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)Edwards Lifesciences2024-06-27DYG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103150438PreviousGS10
00885403521624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103150438006901031504386901031504380690103150438
00885403521624008854035216248854035216240885403521624

GMDN Terms#

Term, Definition table
TermDefinition
Temporary cardiac pacing balloon catheterA sterile, flexible, balloon-tipped, tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker that generates the electrical pacing impulses. It may be unipolar or bipolar and facilitate the display of electrocardiographic signals. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Special Storage Conditions (see IFU)
Special Storage Condition, Specify00Store in a cool, dry place.

Regulatory Flags#

DUNS number
145014099
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
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04
00885403525943TruWavePXMK1714PXMK17142026-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403521174SWAN-GANZBecton, Dickinson And CompanyLDF2026-09-04
00885403521174SWAN-GANZBecton, Dickinson And CompanyDYG2026-09-04
00885403521525SWAN-GANZBecton, Dickinson And CompanyLDF2026-09-04
00885403521525SWAN-GANZBecton, Dickinson And CompanyDYG2026-09-04
00885403522324Swan-GanzBecton, Dickinson And CompanyDYG2026-07-31
00885403522393Swan-GanzBecton, Dickinson And CompanyDYG2026-07-27
00885403522300Swan-GanzBecton, Dickinson And CompanyDYG2026-07-24
00885403522331Swan-GanzBecton, Dickinson And CompanyDYG2026-07-24
00885403522270Swan-GanzBecton, Dickinson And CompanyDYG2026-05-30
00885403522348SWAN-GANZ CCOMBO VBecton, Dickinson And CompanyDYG2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDYG2026-05-30
08886483507166Bipolar Pacing CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.LDF2026-05-04
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
10801902206647ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206715ARROWTELEFLEX INCORPORATEDDYG2022-03-14
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10801902180756ARROWTELEFLEX INCORPORATEDDYG2021-08-11
10801902180237ARROWTELEFLEX INCORPORATEDDYG2021-08-10
10801902180251ARROWTELEFLEX INCORPORATEDDYG2021-08-10
10801902180244ARROWTELEFLEX INCORPORATEDDYG2021-08-09
10801902180275ARROWTELEFLEX INCORPORATEDDYG2021-08-09
10801902180282ARROWTELEFLEX INCORPORATEDDYG2021-08-09
10801902161335ARROWTELEFLEX INCORPORATEDDYG2020-01-27
10801902161359ARROWTELEFLEX INCORPORATEDDYG2020-01-27
10801902161328ARROWTELEFLEX INCORPORATEDDYG2020-01-23
10801902161274ARROWTELEFLEX INCORPORATEDDYG2020-01-21
10801902161298ARROWTELEFLEX INCORPORATEDDYG2020-01-21