# K071574: Stiffer Coaxial Micro-Introducer Kit

- Pathway: 510(k) (Special)
- Applicant: Enpath Medical, Inc.
- Decided: Jul 5, 2007 after 27 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K932323 (1993). 3 ancestors in all.
45 later devices descend from it; 4 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K090372: The Wand Microaccess Safety Introducer (2009), 32 descendants of its own
- K093022: The Picc Wand Peelable Safety Introducer (2010), 31 descendants of its own
- K081697: The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006 (2008), 27 descendants of its own
- K101422: The Power Wand Safety Introducer with an Extended Dwell Catheter (2011), 25 descendants of its own
- K121073: Powerglide Midline Catheter (2012), 19 descendants of its own

## Recalls of this device
- Sep 8, 2016 · Class II · Z-0051-2017: The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath
- Sep 8, 2016 · Class II · Z-0623-2017: Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.

## Indications for use
The Stiffer Coaxial Micro-Introducer Kit is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.

Source page: https://510kreport.com/device/K071574
Methodology: https://510kreport.com/methodology