# K981642: Stablemapr Steerable Intracardiac Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Cardiorhythm
- Decided: Aug 5, 1998 after 89 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.
12 later devices descend from it; 6 cite it directly.
0 of 13 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 Marinr EP catheter: named in the summary without a submission number
- (no number) Irvine Biomedical Steerable Atrial Mapping Inquire H: named in the summary without a submission number
- (no number) Cordis Webster Halo XP Tricuspid Mapping Catheters: named in the summary without a submission number

## Most influential descendants
- K012708: Electrophysiology Catheter (2002), 5 descendants of its own
- K183547: Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter (2019), 1 descendant of its own
- K043393: Reprocessed EP Technologies Electrophysiology Catheters (2005), 1 descendant of its own
- K212593: ViaCath, AcQRate Dx Steerable Catheter (2021), 0 descendants of its own
- K052414: Reprocessed Electrophysiology Catheter (2005), 0 descendants of its own

## Indications for use
The Medtronic CardioRhythm StableMapr catheter is intended for use in diagnostic electrophysiology procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Source page: https://510kreport.com/device/K981642
Methodology: https://510kreport.com/methodology