FDA.reportPublic FDA data

HexaGen™ RF Generator

Primary DI
00763000871864
Brand
HexaGen™ RF Generator
Company
MEDTRONIC, INC.
Model
AFR-00004
Device description
GENERATOR AFR-00004 HEXAGEN RF 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

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
00763000871864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000871864007630008718647630008718640763000871864

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac radio-frequency ablation system generatorAn electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04
00824846003687NABB4K20R42026-07-04
00824846003700NABB4645R212026-07-04
00824846001669NABB12T12R42026-06-28
00824846001843NA9S63R22026-06-28
00824846001850NA11U35R32026-06-28
00824846001614NABB12V43R32026-06-25
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10846835026726Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026726Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026726Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncQZI2026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
00763000954321NAMEDTRONIC, INC.OAD2026-04-30
00763000954321NAMEDTRONIC, INC.QZI2026-04-30
00763000954321NAMEDTRONIC, INC.OAE2026-04-30
05415067052933Current™ST. JUDE MEDICAL, INC.QZI2026-04-20
05415067053893Current™ST. JUDE MEDICAL, INC.QZI2026-04-20
05415067056009Volt™ST. JUDE MEDICAL, INC.QZI2026-02-25