FDA.reportPublic FDA data

NA

Primary DI
00763000871802
Brand
NA
Company
MEDTRONIC, INC.
Model
AFR-00006
Device description
CABLE AFR-00006 EXTENSION 1PK US
Published
2024-11-04
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
QZIPercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterUnknown3
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationUnknown3
QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240013000Sphere-9 Catheter and Affera Ablation SystemMedtronic, Inc.2024-10-24QZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000871802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000871802007630008718027630008718020763000871802

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000954321NAMEDTRONIC, INC.QZI2026-04-30
00763000954321NAMEDTRONIC, INC.OAE2026-04-30
00763000954321NAMEDTRONIC, INC.OAD2026-04-30
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
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-20
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.QZI2026-02-08
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-08
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-08
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
05415067053886Current™ST. JUDE MEDICAL, INC.QZI2026-01-06