# K153093: FIRMap Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Electrophysiology
- Decided: Apr 7, 2016 after 164 days
- Product code: MTD (Catheter, Intracardiac Mapping, High-Density Array)
- 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: 4 generations back to K983171 (1999). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130827: Firmap Catheter, Topera, Inc. (2013) Summary page 4.

## Most influential descendants
- K163709: FIRMap Catheter (2017), 3 descendants of its own
- K223666: Ablacath™ Mapping Catheter (2023), 2 descendants of its own
- K253205: OptiMap Catheter - 50mm (OPTI-CATH2-50) (2026), 1 descendant of its own
- K261012: OptiMap Catheter - 60mm (OPTI-CATH2-60) (2026), 0 descendants of its own

## Indications for use
For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.

Source page: https://510kreport.com/device/K153093
Methodology: https://510kreport.com/methodology