# K990705: Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set

- Pathway: 510(k) (Traditional)
- Applicant: Medamicus, Inc.
- Decided: Jun 28, 1999 after 116 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932323 (1993). 2 ancestors in all.
48 later devices descend from it; 4 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932323: Percutaneous Introducer, Medamicus, Inc. (1993) Summary page 1.
- K974640: Coaxial Dilator Set, Boston Scientific Corp (1998) Summary page 1.

## Most influential descendants
- K071574: Stiffer Coaxial Micro-Introducer Kit (2007), 45 descendants of its own
- 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

## Recalls of this device
- Apr 28, 2014 · Class II · Z-1614-2014: Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.

## Indications for use
The coaxial introducer set 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/K990705
Methodology: https://510kreport.com/methodology