FDA.reportPublic FDA data

FARASTAR™

Primary DI
00191506041663
Brand
FARASTAR™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004PF41M444
Catalog number
M004PF41M444
Device description
Catheter Connection Cable
Published
2024-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QZIPercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230030000FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,Farapulse, Inc.2024-01-30QZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506041663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506041663001915060416631915060416630191506041663

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10846835026726Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
00763000954321NAMEDTRONIC, INC.QZI2026-04-30
05415067052933Current™ST. JUDE MEDICAL, INC.QZI2026-04-20
05415067053893Current™ST. JUDE MEDICAL, INC.QZI2026-04-20
05415067056009Volt™ST. JUDE MEDICAL, INC.QZI2026-02-25
05415067056016Volt™ST. JUDE MEDICAL, INC.QZI2026-02-25
05415067056023Volt™ST. JUDE MEDICAL, INC.QZI2026-02-25
05415067056030Volt™ST. JUDE MEDICAL, INC.QZI2026-02-25
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.QZI2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.QZI2026-02-08
00191506043964FARASTAR™BOSTON SCIENTIFIC CORPORATIONQZI2026-01-20
00191506047207FARAPOINT™BOSTON SCIENTIFIC CORPORATIONQZI2026-01-20
00191506047221FARAPOINT™BOSTON SCIENTIFIC CORPORATIONQZI2026-01-20
00191506055073FARASTAR™BOSTON SCIENTIFIC CORPORATIONQZI2026-01-20
00191506057688FARASTAR™BOSTON SCIENTIFIC CORPORATIONQZI2026-01-20
05415067051417Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051516Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051554Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051615Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051721Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051752Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067051813Current™ST. JUDE MEDICAL, INC.QZI2026-01-06
05415067052919Current™ST. JUDE MEDICAL, INC.QZI2026-01-06