# K963388: Vessel Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Maxxim Medical
- Decided: Mar 11, 1997 after 195 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: 1 generation back to K891022 (1989). 1 ancestor in all.
11 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891022: Introducer for Ptca Guiding Catheters, Argon Medical Corp. (1989) Summary page 1.

## Most influential descendants
- K070749: Estech Percutaneous Insertion Dilator Kit (2007), 10 descendants of its own
- K081940: Avalon Elite Vascular Access Kit (2008), 4 descendants of its own
- K093554: Retroflex Dilator Kit (2010), 2 descendants of its own
- K162181: Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set (2017), 1 descendant of its own
- K123842: Lawmax Dilator (2013), 1 descendant of its own

## Indications for use
To enlarge the opening in a vessel in preparation of percutaneous entry of a catheter.

Source page: https://510kreport.com/device/K963388
Methodology: https://510kreport.com/methodology