# K003782: Constellation Catheter, Model 8031

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Feb 14, 2001 after 69 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.
55 later devices descend from it; 2 cite it directly.
1 of 56 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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.

Source page: https://510kreport.com/device/K003782
Methodology: https://510kreport.com/methodology