# K190132: Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic
- Decided: Jul 30, 2019 after 183 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
Longest line of descent: 1 generation back to K923915 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923915: Torqr Series Diagnostic EP Catheters, Cardiorhythm (1993) Summary page 4.
- K953185: Platinum Series EP Diagnostic Catheters, Medtronic Cardiorhythm (1996) Summary page 4.

## Indications for use
1. The Medtronic Torqr catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies. 2. The Medtronic Soloist catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Source page: https://510kreport.com/device/K190132
Methodology: https://510kreport.com/methodology