# K801113: Dilator, Vessel, for Perc. Catheter.

- Pathway: 510(k) (Traditional)
- Applicant: Alva Medical, Inc.
- Decided: Jul 28, 1980 after 77 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K162389: Medcomp Vessel Dilator (2017), 3 descendants of its own
- K183036: Dilator Sets (2018), 1 descendant of its own
- K210734: Endovascular Dilator and Sets (2021), 0 descendants of its own
- K192283: MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K801113
Methodology: https://510kreport.com/methodology