# K233433: Sphere-9Dx Diagnostic Catheter (AFR-00009)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic
- Decided: Aug 7, 2024 after 300 days
- Product code: MTD (Catheter, Intracardiac Mapping, High-Density Array)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K983171 (1999). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201750: Pentaray Nav eco High-Density Mapping Catheter, Biosense Webster, Inc. (2020) Summary page 5.

## Indications for use
The Sphere-9Dx Diagnostic Catheter is indicated for electrophysiological mapping (recording and stimulation) of cardiac structures in the heart. This catheter is intended to obtain electrograms in the atrial regions of the heart. The catheter provides location information when used with a compatible Affera Mapping System.

Source page: https://510kreport.com/device/K233433
Methodology: https://510kreport.com/methodology