# K953185: Platinum Series EP Diagnostic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Cardiorhythm
- Decided: Apr 15, 1996 after 280 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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) Medtronic CardioRhythm Torqr catheter: named in the summary without a submission number
- (no number) Bard Intracardiac Electrode catheter: named in the summary without a submission number

## Most influential descendants
- K012708: Electrophysiology Catheter (2002), 5 descendants of its own
- K043393: Reprocessed EP Technologies Electrophysiology Catheters (2005), 1 descendant of its own
- K190132: Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter (2019), 0 descendants of its own
- K052414: Reprocessed Electrophysiology Catheter (2005), 0 descendants of its own
- K052603: Reprocessed Daig Livewire Electrophysiology Catheters (2005), 0 descendants of its own

## Indications for use
A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and coronary vessels and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.

Source page: https://510kreport.com/device/K953185
Methodology: https://510kreport.com/methodology