# K163524: Vessel Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Fetzer Medical GmbH & Co. KG
- Decided: Jun 29, 2017 after 196 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.
No later device cites it as a predicate yet.
0 of 3 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.
- K030788: Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators, Geister Medizin Technik GmbH (2003) Summary page 4.

## Indications for use
Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular surgery.

Source page: https://510kreport.com/device/K163524
Methodology: https://510kreport.com/methodology