# K992777: Constellation Catheters, Model 8039

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Nov 12, 1999 after 86 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: 1 generation back to K983171 (1999). 1 ancestor in all.
55 later devices descend from it; 2 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)
- K983171: Constellation Multiple Electrode Pacing and Recording System, Boston Scientific Corp (1999) Summary page 2.

## Most influential descendants
- 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
- K202066: EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled (2020), 17 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 Recording and Pacing Catheter System may also be used for delivery of externally generated pacing stimuli

Source page: https://510kreport.com/device/K992777
Methodology: https://510kreport.com/methodology