Sphere-9™ Catheter

Basic Information

• Brand Name: Sphere-9™ Catheter
• Primary DI: 00763000993269
• Version / Model: AFR-00001
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-08
• Public Version: 1
• Public Version Date: 2026-02-16
• Public Version Status: New
• Public Device Record Key: 9770726c-6ab0-4c80-8960-806fae65e637

Device Description

CATHETER AFR-00001 SPHERE 9 US Q-BIL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QZI	Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation	Unknown		3
OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	Unknown		3
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61785	Cardiac radio-frequency ablation system catheter	A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000993269	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P240013	010

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Catheter shaft length 115 cm
Device Size Text, specify			Catheter diameter 2.7 mm (8F)
Device Size Text, specify			Expandable ablation electrode diameter 9.3 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry