# K092174: Enabler-P Catheter System, Model 3000

- Pathway: 510(k) (Traditional)
- Applicant: Endocross, Ltd.
- Decided: Dec 30, 2009 after 162 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: 7 generations back to K001992 (2000). 11 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082339: Enabler-P Support Catheter, Endocross, Ltd. (2008) Summary page 1.
- K083833: Enabler-P Catheter, 1000 Part Number:1160, Endocross, Ltd. (2009) Summary page 1.
- K942269: Medtronic Everest Inflation Device, Medtronics Interventional Vascular (1994) Summary page 1.
- K024000: Metricath System Comprised of Metricath 1000 Console & Metricath Balloon Catheter, Angiometrx, Inc. (2003) Summary page 1.

## Most influential descendants
- K121763: Multicross Support Catheter (2012), 8 descendants of its own
- K140910: Centercross Catheter (2014), 3 descendants of its own
- K152456: CenterCross Ultra Catheter (2016), 2 descendants of its own
- K143608: NovaCross Microcatheter (2015), 2 descendants of its own
- K160681: CenterCross Ultra Catheter (2016), 1 descendant of its own

## Indications for use
The ENABLER-P Catheter System is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.

Source page: https://510kreport.com/device/K092174
Methodology: https://510kreport.com/methodology