# K062084: 7F Acumen Coronary Sinus Visualization System, Model CSVS-7-67

- Pathway: 510(k) (Special)
- Applicant: Acumen Medical, Inc.
- Decided: Aug 18, 2006 after 28 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K042381: Coronary Sinus Visualization System, Model CSVS5508, Acumen Medical, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K070051: Acumen Insight Endocardial Visualization System (2007), 0 descendants of its own

## Indications for use
The 7F Acumen Coronary Sinus Visualization System is intended to aid in (he visualization off the coronary sinus, 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.

Source page: https://510kreport.com/device/K062084
Methodology: https://510kreport.com/methodology