# K082561: Spectranetics Quick-Cross Extreme Support Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Dec 10, 2008 after 97 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 K935425 (1994). 11 ancestors in all.
18 later devices descend from it; 6 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991059: Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017, Spectranetics Corp. (1999) Summary page 1.
- K022138: Spectranetics 0.035 Support Catheter, Model 518-028, Spectranetics Corp. (2002) Summary page 1.
- K033678: Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 and 518-038, Spectranetics Corp. (2004) Summary page 1.
- K072750: Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066, Spectranetics Corp. (2007) Summary page 1.
- K992051: Radifocus Optitorque, Terumo Medical Corp. (1999) Summary page 1.

## Most influential descendants
- K092396: Spectranetics Quick Cross Extreme Support Catheters (2009), 13 descendants of its own
- K110540: Terumo Support Catheter (2011), 6 descendants of its own
- K173799: NaviCross 0.018 (2018), 2 descendants of its own
- K133539: Total Across (2014), 2 descendants of its own
- K231044: R2P Navicross (2023), 1 descendant of its own

## Indications for use
Quick-Cross ® Extreme Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Source page: https://510kreport.com/device/K082561
Methodology: https://510kreport.com/methodology