# K030788: Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators

- Pathway: 510(k) (Traditional)
- Applicant: Geister Medizin Technik GmbH
- Decided: Jul 12, 2003 after 122 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K100518: Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (2010), 3 descendants of its own
- K183438: Geomed Vascular Dilators (2019), 1 descendant of its own
- K220981: SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (2023), 0 descendants of its own
- K163524: Vessel Dilator (2017), 0 descendants of its own
- K131446: Integra Jarit Heparin Cannulas, Injectors, and Needles (2013), 0 descendants of its own

## Indications for use
GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artcry 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/K030788
Methodology: https://510kreport.com/methodology