# K070051: Acumen Insight Endocardial Visualization System

- Pathway: 510(k) (Traditional)
- Applicant: Acumen Medical, Inc.
- Decided: Apr 6, 2007 after 92 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K893658 (1989). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042381: Coronary Sinus Visualization System, Model CSVS5508, Acumen Medical, Inc. (2004) Summary page 1.
- K062084: 7F Acumen Coronary Sinus Visualization System, Model CSVS-7-67, Acumen Medical, Inc. (2006) Summary page 1.
- K992631: Acunav Diagnostic Ultrasound Catheter, Acuson Corp. (1999) Summary page 1.

## Indications for use
The Insight Endocardial Visualization System is intended to aid in the visualization of the coronary sinus, foramen ovale and other venous and cardiac anatomy, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart. The Insight is intended for use in the right heart only.

Source page: https://510kreport.com/device/K070051
Methodology: https://510kreport.com/methodology