# K050808: Coronary Sinus Access Kit, Model KCS8F-01

- Pathway: 510(k) (Traditional)
- Applicant: Cardio-Optics, Inc.
- Decided: Jul 28, 2005 after 120 days
- Product code: LYK (Angioscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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.
1 later device descends from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911278: Olympus AF Angioscope System, Olympus Corp. (1991) Summary page 1.
- K860858: Olympus PF-18 & PF-25 Ultrathin Angioscope, Olympus Corp. (1986) Summary page 1.
- K955817: Coridis Webster Deflectable Braided-Tip Electrode Catheter, Cordis Webster, Inc. (1996) Summary page 1.
- K031906: Apeel CS Catheter Delivery System, St Jude Medical (2003) Summary page 1.
- K003731: Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve, Thomas Medical Products, Inc. (2001) Summary page 1.
- K042381: Coronary Sinus Visualization System, Model CSVS5508, Acumen Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K062340: Cardiooptics Augmentative Cardiac Optical Imaging System (2006), 0 descendants of its own

## Indications for use
The CardioOptics Coronary Sinus Access (CSATM ) System is intended to provide subclavian access to the right heart for accessing the coronary sinus and placing a guide sheath suitable for pacemaker lead implantation into the coronary sinus. The system includes visualization means to image anatomical structures to augment navigation.

Source page: https://510kreport.com/device/K050808
Methodology: https://510kreport.com/methodology