FDA.reportPublic FDA data

Current™

Primary DI
05415067052933
Brand
Current™
Company
ST. JUDE MEDICAL, INC.
Model
A-UNI-PF-CBL
Catalog number
A-UNI-PF-CBL
Device description
PFA Unified Cable
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
P250022003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250022003Volt™ PFA SystemABBOTT MEDICAL2025-12-19QZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067052933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067052933054150670529335415067052933

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA 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. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length363Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067033307Amplatzer™ Talisman™9-PFO-18189-PFO-18182021-09-29
05415067033314Amplatzer™ Talisman™9-PFO-25189-PFO-25182021-09-29
05415067033321Amplatzer™ Talisman™9-PFO-30259-PFO-30252021-09-29
05415067033345Amplatzer™ Talisman™9-PFO-35259-PFO-35252021-09-29
00811806011103Amplatzer™9-PDA-0039-PDA-0032014-09-08
00811806011110Amplatzer™9-PDA-0049-PDA-0042014-09-08
00811806011127Amplatzer™9-PDA-0059-PDA-0052014-09-08
00811806011134Amplatzer™9-PDA-0069-PDA-0062014-09-08
00811806011141Amplatzer™9-PDA-0079-PDA-0072014-09-08
00811806011172Amplatzer™9-PDA2-03-049-PDA2-03-042014-09-08
00811806011189Amplatzer™9-PDA2-03-069-PDA2-03-062014-09-19
00811806011202Amplatzer™9-PDA2-04-049-PDA2-04-042014-09-15
00811806011219Amplatzer™9-PDA2-04-069-PDA2-04-062014-09-15
00811806011233Amplatzer™9-PDA2-05-049-PDA2-05-042014-09-15
00811806011240Amplatzer™9-PDA2-05-069-PDA2-05-062014-09-15
00811806011257Amplatzer™9-PDA2-06-049-PDA2-06-042014-09-15
00811806011264Amplatzer™9-PDA2-06-069-PDA2-06-062014-09-15
05415067031570Navitor™NVTR-23NVTR-232023-01-16
05415067031587Navitor™NVTR-25NVTR-252023-01-16
05415067031594Navitor™NVTR-27NVTR-272023-01-16

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