FDA.reportPublic FDA data

FARAPOINT™

Primary DI
00191506047207
Brand
FARAPOINT™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004PF81M110
Catalog number
M004PF81M110
Device description
Pulsed Field Ablation Catheter
Published
2026-01-20
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
P230030012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230030012FARAPULSE™ 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
00191506047207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506047207001915060472071915060472070191506047207

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac irreversible electroporation system catheterA flexible tube with an electrode array its distal end designed to be used as part of a cardiac irreversible electroporation system to apply a series of microsecond electrical pulses to ablate endocardial tissues through irreversible electroporation, to treat cardiac arrhythmia. It is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is designed to be introduced into the heart via venous access (e.g., femoral vein). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2.7Millimeter

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
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
05415067053022Volt™ PFA Sensor Enabled™ST. JUDE MEDICAL, INC.QZI2026-01-06