# K030260: Gelbfish Flex Vascular Dilator

- Pathway: 510(k) (Special)
- Applicant: Vascumetrix, LLC
- Decided: Feb 20, 2003 after 27 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- 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 K974617 (1998). 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)
- K012256: Gelbish Vascular Dilator, Vascumetrix, LLC (2001)

## Indications for use
These devices are intended to be used over a guidewire to dilate or calibrate blood vessels.

Source page: https://510kreport.com/device/K030260
Methodology: https://510kreport.com/methodology