# K021232: Constellation Catheters, Model 8031M

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: May 16, 2002 after 28 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: 2 generations back to K983171 (1999). 4 ancestors in all.
54 later devices descend from it; 3 cite it directly.
1 of 59 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.
- K992777: Constellation Catheters, Model 8039, Boston Scientific Corp (1999) Summary page 2.
- K000277: Constellation Catheters, Boston Scientific Corp (2000) Summary page 2.
- K003782: Constellation Catheter, Model 8031, Boston Scientific Corp (2001) Summary page 2.

## Most influential descendants
- 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
- K212061: EnSite X EP System (2021), 13 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 arthythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Constellation® Multiple Electrode Recording and Pacing Catheters System may also be used for delivery of externally generated pacing stimuli.

Source page: https://510kreport.com/device/K021232
Methodology: https://510kreport.com/methodology