# K101399: Coaxial Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Martech Medical Products
- Decided: Jun 17, 2010 after 30 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: 4 generations back to K932323 (1993). 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)
- K091954: Micro-Stick Set, Medcomp (2010) Summary page 1.

## Indications for use
The Coaxial Introducer 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 Coaxial Introducer Set is not intended for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K101399
Methodology: https://510kreport.com/methodology