# K983653: Radii Diagnostic Electrophysiology Catheter, Model # 30411 B, C and D

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Pathways Corp.
- Decided: Dec 22, 1998 after 64 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Polaris-Dx™ Steerable Diagnostic Catheter: named in the summary without a submission number
- (no number) EPT-Dx™: named in the summary without a submission number
- (no number) Diagnostic/Ablation Large & Grooved Dome Deflectable Catheters: named in the summary without a submission number

## Indications for use
The Radii Diagnostic Electrophysiologic Catheter is intended to be used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure.

Source page: https://510kreport.com/device/K983653
Methodology: https://510kreport.com/methodology