# K952638: 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the Modified Angioscope[

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Edwards
- Decided: Jul 28, 1995 after 49 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
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023548: Proxis Flow-Control Device, Models Eps 101, IC 101 (2003), 6 descendants of its own
- K042117: Proxis System, Model Eps 101 (2005), 5 descendants of its own
- K060651: Proxis System, Model EPS101 (2006), 3 descendants of its own
- K042381: Coronary Sinus Visualization System, Model CSVS5508 (2004), 3 descendants of its own
- K052523: Proxis System (2006), 2 descendants of its own

Source page: https://510kreport.com/device/K952638
Methodology: https://510kreport.com/methodology
