# K013349: Astronomer Plus System

- Pathway: 510(k) (Abbreviated)
- Applicant: Ep Technologies, Inc.
- Decided: Apr 9, 2002 after 182 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954395 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003362: Astronomer+with SLD, Boston Scientific Corp (2001) Summary page 1.
- K992912: Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac Pathways Radii Catheter and Radii Cath, Cardiac Pathways Corp. (2000) Summary page 1.
- K992968: Carto EP Navigation System, Biosense Webster, Inc. (1999) Summary page 1.
- K001437: Ensite 3000 System, Model EE3000, Endocardial Solutions, Inc. (2000) Summary page 1.
- K002869: Localisa Cardiac Navigation System, Medtronic Surgical Navigation Technologies (2001) Summary page 1.

## Indications for use
The Astronomer Plus™ System is a computerized system to assist in the diagnosis of complex cardiac arrhythmias. The Astronomer Plus™ System can be used to: + Display the relative location of catheters during cardiac mapping procedures (used exclusively with the Constellation® Catheter); * Route externally generated pacing stimuli and transmit cardiac electrogram (EGM) signals to electrophysiology recorders; and * Document electrophysiological procedures which make use of the Constellation® Catheter.

Source page: https://510kreport.com/device/K013349
Methodology: https://510kreport.com/methodology