# K183438: Geomed Vascular Dilators

- Pathway: 510(k) (Traditional)
- Applicant: Geomed Medizin-Technik GmbH & Co.
- Decided: Sep 3, 2019 after 265 days
- Product code: DWP (Dilator, Vessel, Surgical)
- Device class: 2
- Regulation: 21 CFR 870.4475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K030788 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100518: Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054, Instrumed International, Inc. (2010) Summary page 4.

## Most influential descendants
- K220981: SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (2023), 0 descendants of its own

## Indications for use
Geomed Vascular Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

Source page: https://510kreport.com/device/K183438
Methodology: https://510kreport.com/methodology