# K983171: Constellation Multiple Electrode Pacing and Recording System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 11, 1999 after 182 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
No predicates in its family tree.
56 later devices descend from it; 3 cite it directly.
1 of 57 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K992777: Constellation Catheters, Model 8039 (1999), 55 descendants of its own
- K021232: Constellation Catheters, Model 8031M (2002), 54 descendants of its own
- K050217: Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode Spacing) (2005), 39 descendants of its own
- K120425: Pentaray Nav High-Density Mapping Catheter (2012), 34 descendants of its own
- K172393: Advisor HD Grid Mapping Catheter, Sensor Enabled (2018), 21 descendants of its own

## Recalls of this device
- Feb 14, 2005 · Not classified · Z-0639-05: The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.

## Indications for use
For use in right 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 Mapping Catheter may also be used to deliver externally generated pacing stimuli.

Source page: https://510kreport.com/device/K983171
Methodology: https://510kreport.com/methodology