# K082339: Enabler-P Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Endocross, Ltd.
- Decided: Nov 20, 2008 after 98 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 K001992 (2000). 7 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051772: Asahi Tornus Support Catheter, Asahi Intecc Co., Ltd. (2005)
- K011889: Ultra -Thin SDS Balloon Dilatation Catheter, Boston Scientific Corp (2001) Summary page 1.
- K001992: Ilt 0.014 Catheter, Model C114NL2, Intra Luminal Therapeutics, Inc. (2000)

## Most influential descendants
- K083833: Enabler-P Catheter, 1000 Part Number:1160 (2009), 12 descendants of its own
- K092174: Enabler-P Catheter System, Model 3000 (2009), 9 descendants of its own
- 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

## Indications for use
The ENABLER-P Support Catheter 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/K082339
Methodology: https://510kreport.com/methodology
