# K043489: Enpath Deflectable Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Enpath Medical Incorporated
- Decided: May 19, 2005 after 153 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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: 4 generations back to K893658 (1989). 35 ancestors in all.
13 later devices descend from it; 3 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)
- K013517: 10600 Deflectable Catheter System, Model 10600, Medtronic Vascular (2002) Summary page 1.

## Most influential descendants
- K061119: Enpath Medical Steerable Sheath (2006), 10 descendants of its own
- 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

## Recalls of this device
- Jun 27, 2006 · Not classified · Z-0118-2007: Enpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.
- Aug 31, 2005 · Not classified · Z-1573-05: Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hol

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

Source page: https://510kreport.com/device/K043489
Methodology: https://510kreport.com/methodology