# K130827: Firmap Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Topera, Inc.
- Decided: Oct 31, 2013 after 219 days
- Product code: MTD (Catheter, Intracardiac Mapping, High-Density Array)
- 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
Longest line of descent: 3 generations back to K983171 (1999). 5 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021232: Constellation Catheters, Model 8031M, Boston Scientific Corp (2002) Summary page 1.

## Most influential descendants
- K142901: RhythmView Workstation (2014), 6 descendants of its own
- K151245: Rhythm View Workstation (non-streaming, steaming option) (2015), 5 descendants of its own
- K161240: Rhythm View Workstation (non-streaming) (2016), 4 descendants of its own
- K153093: FIRMap Catheter (2016), 4 descendants of its own
- K171583: RhythmView Workstation (2017), 3 descendants of its own

## Recalls of this device
- Aug 12, 2015 · Class III · Z-2478-2015: The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date.

## 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 Topera FIRMap Tm Catheter may also be used for delivery of externally generated pacing stimuli.

Source page: https://510kreport.com/device/K130827
Methodology: https://510kreport.com/methodology