# K891022: Introducer for Ptca Guiding Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Corp.
- Decided: May 19, 1989 after 80 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K963388: Vessel Dilator (1997), 11 descendants of its own
- 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

Source page: https://510kreport.com/device/K891022
Methodology: https://510kreport.com/methodology