# K042381: Coronary Sinus Visualization System, Model CSVS5508

- Pathway: 510(k) (Traditional)
- Applicant: Acumen Medical, Inc.
- Decided: Dec 28, 2004 after 118 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: 6 generations back to K893658 (1989). 47 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032622: Attain Prevail Left Heart Delivery System Moddel, 6228SYS, Medtronic Vascular (2003) Summary page 1.
- K973298: Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter, Cardima, Inc. (1998) Summary page 1.
- K952638: 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the Modified Angioscope[, Baxter Edwards (1995) Summary page 1.
- K960081: Battery Powered Endosccopic Light Source, Mitsubishi Cable America, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K855529: CCD Solid State Video Camera. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K050808: Coronary Sinus Access Kit, Model KCS8F-01 (2005), 1 descendant of its own
- K070051: Acumen Insight Endocardial Visualization System (2007), 0 descendants of its own
- K062340: Cardiooptics Augmentative Cardiac Optical Imaging System (2006), 0 descendants of its own

## Indications for use
The Acumen Coronary Sinus Visualization System is intended to aid in the visualization of 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/K042381
Methodology: https://510kreport.com/methodology