# K020563: Medamicus Axia RSN

- Pathway: 510(k) (Traditional)
- Applicant: Medamicus, Inc.
- Decided: May 21, 2002 after 90 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: 1 generation back to K971165 (1997). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011085: Guidewire Introducer Safety Needle, Medamicus, Inc. (2001) Summary page 2.
- K971165: Introducer Sheath and Dilator, Boston Scientific Corp (1997) Summary page 1.

## Most influential descendants
- K022689: Modification to Medamicus Axia RSN (2002), 2 descendants of its own
- K040029: Safetynet Guidewire Introducer (2004), 1 descendant of its own
- K073664: Frontline Medical Safetynet Guidewire Introducer (2008), 0 descendants of its own

## Indications for use
The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires or other devices.

Source page: https://510kreport.com/device/K020563
Methodology: https://510kreport.com/methodology