# K091954: Micro-Stick Set

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Jan 8, 2010 after 191 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
Longest line of descent: 3 generations back to K932323 (1993). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071574: Stiffer Coaxial Micro-Introducer Kit, Enpath Medical, Inc. (2007) Summary page 1.
- K990705: Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set, Medamicus, Inc. (1999) Summary page 1.

## Most influential descendants
- K130855: Ptfe Super Sheath Introducer (2013), 1 descendant of its own
- K153246: PTFE Super Sheath Introducer 2.1 (2016), 0 descendants of its own
- K101399: Coaxial Introducer Set (2010), 0 descendants of its own

## Indications for use
The Micro-Stick® Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Micro-Stick® Set is not intended for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K091954
Methodology: https://510kreport.com/methodology