# K210734: Endovascular Dilator and Sets

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Apr 6, 2021 after 26 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: 3 generations back to K961904 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183036: Dilator Sets, Cook Incorporated (2018) Summary page 5.

## Indications for use
Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular applications in the arterial system.

Source page: https://510kreport.com/device/K210734
Methodology: https://510kreport.com/methodology