# K992912: Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac Pathways Radii Catheter and Radii Cath

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Pathways Corp.
- Decided: Mar 8, 2000 after 191 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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) Biosense Carto™ System: named in the summary without a submission number
- (no number) Radii™ Diagnostic Electrophysiology Catheter: named in the summary without a submission number
- (no number) Navi-Star® Catheter: named in the summary without a submission number
- (no number) Fixed Curve Diagnostic Electrophysiology Catheter: named in the summary without a submission number
- (no number) Ref-Star® Catheter: named in the summary without a submission number
- (no number) 5F SUPRA CS™ Diagnostic Electrophysiology Catheter: named in the summary without a submission number

## Most influential descendants
- K043257: Real-Time Position Management (RPM) System (2005), 0 descendants of its own
- K013349: Astronomer Plus System (2002), 0 descendants of its own

## Recalls of this device
- Mar 14, 2005 · Not classified · Z-0112-06: The device has the potential for overheating its transformer and has the potential for fire hazard.

## Indications for use
The Cardiac Pathways Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Arrhythmia Mapping and Tracking System to provide catheter location information.

Source page: https://510kreport.com/device/K992912
Methodology: https://510kreport.com/methodology