# K061119: Enpath Medical Steerable Sheath

- Pathway: 510(k) (Special)
- Applicant: Enpath Medical, Inc.
- Decided: May 18, 2006 after 27 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K893658 (1989). 36 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043489: Enpath Deflectable Catheter, Enpath Medical Incorporated (2005) Summary page 1.

## Most influential descendants
- K122960: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own
- K151951: Destino Reach (2015), 6 descendants of its own
- K240829: AuST Steerable Sheath (2024), 5 descendants of its own
- K242106: AuST Steerable Sheath (2024), 4 descendants of its own
- K251051: AuST Steerable Sheath (2025), 3 descendants of its own

## Indications for use
The Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.

Source page: https://510kreport.com/device/K061119
Methodology: https://510kreport.com/methodology