# K140733: Constellation Multiple Electrode Recording & Pacing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Apr 28, 2014 after 35 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). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983171: Constellation Multiple Electrode Pacing and Recording System, Boston Scientific Corp (1999) Summary page 1.
- K992777: Constellation Catheters, Model 8039, Boston Scientific Corp (1999) Summary page 1.
- K000277: Constellation Catheters, Boston Scientific Corp (2000) Summary page 1.
- K003782: Constellation Catheter, Model 8031, Boston Scientific Corp (2001) Summary page 1.
- K021232: Constellation Catheters, Model 8031M, Boston Scientific Corp (2002) Summary page 1.
- K050217: Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode Spacing), Biosense Webster, Inc. (2005) Summary page 1.

## Most influential descendants
- K170819: AcQMap 3D Imaging and Mapping Catheter (2017), 2 descendants of its own
- K201341: AcQMap 3D Imaging and Mapping Catheter (2020), 1 descendant of its own
- K210766: AcQMap 3D Imaging and Mapping Catheter, Model 900009 (2022), 0 descendants of its own

## Indications for use
For use in right and left atrial 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 Constellation Multiple Electrode Recording and Pacing Catheter System may also be used for delivery of externally generated pacing stimuli.

Source page: https://510kreport.com/device/K140733
Methodology: https://510kreport.com/methodology